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Showing posts sorted by date for query calmare. Sort by relevance Show all posts

Friday, May 2, 2014

The Genius Behind CALMARE and CTTC: Meet Giuseppe "The Vulture" Marineo

I've not mentioned CALMARE in quite some time.  First, I had one of its ardent supporters ask me to please "leave me alone," and the whine rang through the writing such that I felt guilty for the poor man. Then, my disgust having reached such an acidic state, it was either fork over another $100 for stomach medication or ignore the scam, ignore the scammers, including poor Joey and his "leave me alone" [sniff, sniff].

Actually, what came first was an extraordinarily prayerful woman badgering me on YouTube -- so well known for the quality of its commentary -- when I did not praise her Lord and sign up for Calmare treatments immediately.  They cured one of her offspring, you see.  She repeated a bunch of FDA rubbish, then some VA rubbish, then plain rubbish.  Then she got personal.  Anyway.

I conducted myself with my usual bendy, bendy politeness, and watched as she moved on to praise her Lord in the comment section of other people suffering with CRPS.  It was almost as if she were paid to do it, or something.  Anyway.

CTTC is the corporate entity that markets CALMARE / Scrambler Therapy as a cure for various neuropathies, including CRPS, post-herpetic neuralgias, and the nerve pain that can be engendered by chemotherapies.  It's crucial that the public understand that CTTC does nothing but coopt the patents for various products.  CTTC sells its soul to sell, it does not have any real investment in the product, and in this case, the patients -- just in the public perception of the product, and how cheaply they can buy up patents.

In their fertilization of the advertising world with CALMARE and CALMARE-related pellets of untruth, CTTC peppers social media, patient support groups, and advertisements dressed up as pain management newsletters or health-related articles decorated as actual research.  Videos have been widely distributed, starring cured patients who tearfully recall their prior suffering state, while never documenting that state in the recordings.  The Testimonial approach to CALMARE / Scrambler Therapy duplicates the get-rich-quick late night infomercial -- in methodology as in message (tremendous, too good to believe results with no effort beyond prying loose a credit card from a tight wallet).

I have many favorite lines among the testimonialists.  Right now it's I-am-so-thankful-for-Calmare because (prepare to weep):

"I have an allergic reaction to all medications. I cannot even have chemotherapy with stage 4 cancer."

I am not without a tender heart, as I ponder all the people I have known whose bodies relished the poisons of their chemotherapies and who never had any distressing reaction to the harsh chemicals coursing through their systems, at all.

The Straight Dope message board, my source for straight dope messages, once briefly contemplated how these remarkable testimonials come to life:

User ARCHETYPE, a naive sort, starts the conversation:
Infomercial testimonials
How do they get people to so convincingly testify in those infomercials?
Some (especially the latest ab gadget or those get-rich-quick products) are scams and the thing that gets me most is how they get these people to so convincingly testify. Some infomercials even state that their testifiers are not compensated.
It boggles me in three levels:
1) You KNOW the product can never work as advertised.
Home-based businesses. After researching some of the home-based business on the net and discovering how their scams actually work and reading unfortunate purchasers' stories you know it is not as simple as "making $12,000 for a few hours of work in my spare time in my underwear."
The latest ab gadget. Losing weight involves diet and much more significant exercise, cardio, etc. than just crunching the damn machine 5 minutes a day.
2) This applies more to products that are brand new in the market (I can't think of any specific ones at this moment!). But how do they find the people who have used a certain product it for X amount of months or years when you know that this is the first time it is being advertised?
Now, I'm aware of such things as test markets but how do they market to those test markets? And how do they find people who had success with their products when it clearly cannot work and convince these people to testify for their product?
3) What's in it for these testifiers? Is it a lot of money? Aren't they afraid their friends and family might see their testimony?

So how do they get these testimonies? Are they all lying and/or are paid actors despite the disclaimers that they are not?

ARCHTYPE receives many thoughtful responses, but I think the essence of them all is best encapsulated by user T-BONHAM:


They lie. LIE.
After all, if you are ripping people off by selling them a product that does not work, why would you hesitate to lie about testimonials?
Think of the marketing of CALMARE / Scrambler Therapy as some sort of magic act.  Most such performances rely on distraction, sleight of hand, a spot light drawing the eye from the unlit area of ruse.

Most recently, I came upon a much-marketed CTTC/CALMARE/Scrambler Therapy saleswoman who has done her bit with a series of videos, and for the cream and cherry on top, she has a blog.  What's fascinating is that her blog, with scant entries over the years, never mentions her intense suffering from a "pain condition," until CALMARE enters the textual scene.  And, then, she does not mention CRPS! It's as if she and her corporate backers are afraid of being too specific.  She gives a semi-accurate description of CRPS but doesn't want to worry her readers or cause friends and family to fret by saying exactly what horrid "pain condition" is beleaguering those poor legs of hers... Good thing that her bogus treatments worked wonders, though she adds that indelible soupçon of believability by mentioning that she may have to have "booster" treatments.

Her name was Amanda, Amanda Something.  For some sick reason, whenever I look up her name, Phil Ochs' song "Miranda" * jumps my brain, and I find myself humming along with my sober researching. 

In the beginning, much was made of the inventor and original patent holder, Giuseppe Marineo.  He was called, falsely, "doctor" and "professor."  As he became more of an embarrassment, he received more in the way of money and CTTC got more in the way of "ownership" of the miracle device, so the marketing geniuses could begin to fashion the background into which he might fade.

As various gynecologists and chiropractors, stethoscopes slung rakishly about their necks, receptionists shadowing them in short white coats, took over the public face of CALMARE / Scrambler Therapy -- along with some of the strangest testimonial-givers on the planet -- the "scientist" behind the earth-shattering souped-up TENS unit was cast into oblivion.

No one bothered to answer questions relating to his claims and intentions.  

How did this machine come to be a treatment specific for intractable neuropathic pain when it began as Giuseppe Marineo's personal brand of woo, wrapped in a fake curriculum vitae, protected and obscured by Delta R&D, his "bioengineering research centre with a unique history."  Marineo's goal was apparently the creation of a device in the tradition of the Fountain of Youth, a modulated electric buzz that would retard aging at the cellular level.

Woo, woo. A quick woo primer:

Woo generally contains most of the following characteristics:

  • A simple idea that purports to be the one answer to many problems (often including diseases)
  • A "scientific-sounding" reason for how it works, but little to no actual science behind it; for example, quote mines of studies that if bent enough could be described in such a way to support it, outright misapplication of studies, or words that sound scientific but make no sense in the context they are used in
  • It involves the supernatural and paranormal (not necessarily)
  • A claim of persecution, usually perpetrated by the government or the pharmaceutical, medical, or scientific community
  • An invocation of a scientific authority
  • Prefers to use abundant testimonials over actual scientific research
  • A claim that scientists are blind to the discovery, despite attempts to alert them
  • A disdain for objective, randomized experimental controls, especially double-blind testing (which are kind of what makes epidemiology actually, y'know, work)
  • And, usually, an offer to share the knowledge for a price.
Oh, the woo you are about to muddle through!

Put on your waders, and unpack this introduction to how Marineo went from a one-man show to an incorporated one-man show with a tenuous connection to a research university.
[Delta R & D] was born out of individual research work begun in 1983 by Giuseppe Marineo, a researcher and bioengineer, who advanced theories to reformulate the concept of disease (and the corresponding treatment) from a biophysical rather than biochemical point of view. The idea was to restructure the known features of both according to the principles of thermodynamics by means of an analysis and the detailed specification of the relations between entropy, disease, repair processes and ageing.

This new approach to the interpretation of the traditional aspects of medical science makes it possible to go from a highly heuristic system to an extremely conceptual and rationalized system, which can create models of disease and treatment so sophisticated as to render the experimental results highly predictable. If the latter are in line with the predictions they automatically validate the development model.  
Furthermore, the very name of the theoretical system developed entails a natural transition from reductionist methods to systems theory which, in the present research, takes the form of a powerful working tool capable of providing adequate support for the development of therapies of practical utility.

In practice Marineo introduced into medical science the research and development criteria typical of engineering, in which the thoroughness of the preliminary theoretical work fully determines the expectations of the experimental verification of the method used. In 1987 the basic research was already sufficiently well structured to be supported by a technology capable of translating the theoretical system into a truly useful therapy.

The first experimental verifications fully confirmed the validity of the theoretical models developed and opened up concrete future prospects for the safe and non-invasive treatment of pathologies for which conventional methods had proved ineffective.
In 1998 the Italian scientific community, which had been constantly informed of all research developments, deemed the product of 15 years research to be scientifically valid, the theoretical principles and experimental data to have been clearly demonstrated and the bioethical principles regarding the respect and protection of the patient to have been respected.

In other words, the research carried out by a private individual was accepted and supported by the public authorities. It was consequently possible to begin official university and hospital studies, at the conclusion of which the first international publications were produced.

In order to support these changes, in May 1998 Delta R&D was set up, thus marking the beginning of the mature stage of this individual research endeavour. Although the original philosophy was retained, a logistical structure was now available to satisfy the new phases of development and to maintain and expand relations with the international scientific community. 

I dare you to unpack this into meaningful language reflective of actual science, or even good business.
Or this, from a website now removed, written by the great Marineo, himself:

The assumed pre-coding capacity is a more logical explanation than stochastic fluctuation (which in this case must be re-interpreted as a consistent modification of the information content per stimulus/time) the different discharge time characteristic used by the receptor for the same stimulus if this occurs in sufficiently short time intervals. In this perspective, to return to our model, the comparator?? Is the arbitrary module that sorts the information, compares it with a short-term memory and if it recognizes a stimulus similar to the preceding one, modifies the gain data and the information property which it passes on to the amplifier/attenuator (synapsis), a vital element that controls the passage/non passage of the “decoded” information stripped of spurious signals, associating it with the correct degree of intensity. Again with reference to the model, the noise and stochastic variations are separated since, in my analysis, at least some of these fluctuations actually consist of sub-information capable of modifying the learning capacity and sensitivity to the stimulus if repeated over short time intervals. If the data are reinterpreted in this sense, frequency modulated discharge sequences immediately took on a different significance when combined with the “pseudo-noise” modulation accompanying them and which became an essential element of the “primary” information. At this stage I considered that I had all the elements required to materially construct a pain scrambler (technically an information mixer), that is, a system capable of “masking” the pain signal.

Here's another, still extant (if badly translated by Google -- I apologize for my lack of skill in Italian) version of the the birth of the great regenerative process, the Scrambler Therapy.  Marineo simply MUST have a genetic link with the superb Ponce de Leon.  This comes in an English version... already cited.  It was fascinating to pick my way through the Italian, which bears little to no relation to its bastard English cousin.

In the mid 80s I completed the development of a theoretical model that interpreted on the basis of biophysical dynamics of chronic-degenerative disease processes, and more generally of an aging workforce. On the basis of this theoretical model I have subsequently developed a technology (Systems Entropy Variation Delta-S) in accordance with these principles that was potentially able to reactivate regenerative processes of tissues and organs without the use of stem cells.
In 2003, this research has received European approval for use in ambulatory and hospital liver cirrhosis. The results of phase II studies have been published in the Annals of the Academy of Sciences in New York and in other publications indexed. Despite this initial success, for reasons related to the lack of industrial sponsors, I found myself in substantial economic impossibility of progression in phase III clinical trials.
This research dissemination in the scientific community was so overcome by what I later developed the chronic pain, now known as the Scrambler Therapy ®. Contrary to what many believe, the "Scrambler Therapy ®" was born almost accidentally and indirectly from my studies on regeneration, although initially considered (sbagliandomi) only support the latter.
In particular in the field of regeneration in the late 80s I developed two lines of experimentation leading to verify if the theoretical assumptions that I had assumed were actually used in the clinic even humans. The first line of research related to cirrhosis of the liver, where the chances of success were predictably higher for most hepatic regenerative capacity of the organ.
The second line of research instead on the regeneration of nerve fibers, almost a complete utopia in those days, even if Rita Levi Montalcini had just got the Nobel (December 1986) for the discovery of 'NGF, the growth factor of nerve fibers . Inevitably occupandomi nerve injury I got in touch with what is, by definition, considered the worst form of chronic pain that is known in medicine, neuropathic, which essentially prevented the possibility to study the possibilities of regenerative nerve damage. Initially I sought the help of specialists in pain, but when I spoke of neuropathic pain were more discouraged me.
For a long time I turned to all sorts of pain specialist, seeking solutions also in acupuncture and hypnosis clinic, but the pain seemed to resist any attempt at treatment. I was about to resign myself to this situation by deciding to continue my research only on cirrhosis of the liver, where although always of limited series, I had already obtained preliminary results very encouraging, and free of the problems related to chronic pain that I met in nerve damage.
Just a few days as I was maturing this decision, an 'association of ill asked me to attend one of their meetings. I accepted, and put it back in the face of so much suffering and hopes of these people, I decided that if there was still no effective treatment for these types of pain, this does not necessarily meant that it was impossible to do so.
My knowledge of neurophysiology were already quite wide and deep, I was not so difficult to integrate with the specialized knowledge of the pathophysiology of chronic pain. Just as approfondivo this knowledge met the Gate Control theory, that is the dominant model and commonly accepted understanding of the mechanisms of pain perception. With some surprise I immediately realized that this theory was applicable only in acute pain. Conversely, I could not find at all its logical application in chronic pain, although conventionally accepted in the scientific community.
I understood that my assessment was practically heresy given the importance of this theory, the weight of scientific authors, endorsements obtained from its inception, and subsequent to the full consecration obtained after the seminal article published in Science in 1965. Then Thinking that he had missed something, I continued to deepen my studies, but most did this, the more my belief dell'inapplicabilità of this theory to chronic pain (especially neuropathic) prevailed.
I can say that it is exactly at this moment that comes Scrambler Therapy ®, because by identifying what I thought an error, I also found the way to a possible solution, which is now a clinical reality no longer experimental
About had enough?  Take a break from this thick, smarmy scientific writing and read something uplifting.


Calmare for Nobel Prize: Calmare Inventor Giuseppe Marineo is recieving some groundswell of support for a Nobel Prize this year, in the Physics, Chemistry, and Medical categories (he can only win one category) due to his invention of the Calmare medical device which cures pain without the side effects of narcotics.

Damn the limitation that keeps Giuseppe from winning in every category.  It makes a mockery of the man's work.

Or you can slog on, maybe picking up a copy of the story of his AIDS cure, available on eBay at the moment:  Dall' Altra Parte (The Other Side) for a mere 9 Euros.  There are other stories, besides his own tale, of his electromagnetic cure, notable at the time as it was being "tested" on poet Dario Belleza, and resulted in a charge of practicing medicine without a license and vaguely familiar charges of "totally inconclusive data."

Denying he had AIDS, commonplace enough for the times, Belleza told interviewers:

"The treatment was reserved for a group of five people," concludes Dario Bellezza "because the machine was not powerful enough. No one was tied to the bed, as it was written, it only used electrodes and patches to apply them."  

The electromagnetic machine, which worked through patched electrodes... WAIT!  That sounds VAGUELY familiar!  Could it have been, GASP, just an earlier version of the scrambling pain-hexer, the miraculous Calmare, now being snake-oil-marketed by Calmare?

It was further described in the press as witchcraft and charlatanism

Granted, what Marineo and the dead poet brought up in a war fought in the courts as well as the press, that people have the right to "diversity" of treatment, and to treatment considered "alternative," is a valid argument.

It's just painful to watch a vulture move from one corpse to the next, one hopeless illness to another, reaping, reaping, hopping away, with strips of flailed skin flapping from its beak, feeding itself... and divesting its prey of all humanity.

Is that over the top?  
Is it, really?
















* Miranda lyrics, so that you, too, may hum along:


Do you have a problem,
Would you like someone to solve them,
Would you like someone to share in your misery?
Now, I don't know the answer, but I know a flamenco dancer
Who will dance for you if you will dance for me

[Chorus:]
Her name's Miranda
She's a Rudolph Valentino fan
And she doesn't claim to understand
She bakes brownies for the boys in the band.

Early Sunday morning
When the sermon lines are forming
And Saturday night is the memories that it gave.
She's busy in the pantry, far away from Elmer Gantry
Who is busy baking souls that he may save.
Everybody's soul but Miranda (Chorus)
The dice of death are calling
While the truck of time is falling
By the thumb stuck out on the highway of the years.
The tollgate at the turnpike is ignored by those who hitch-hike
And the Howard Johnson food is made of fear
But not Miranda 

(Chorus)

The sun burnt skin is peeling
On the doctors who are healing
And the license plates are laughing on the car.
The pain is so exciting
And everyone's inviting
You to look upon their operation scars.
But not Miranda 

(Chorus)

The condiments are clashing
While commercial planes are crashing
And the music of the evening is so sweet
Now fully in agreement
Oh, their feet have found the cement
And they all believe the signs are on the street
Her name's Miranda 

(Chorus)

In the bar we're gin and scotching
While the FBI is watching
They are tape recording every other word
The bartender is bleeding
Pardon me, I just was leaving
as another clever voice repeats absurd
But not Miranda 

(Chorus)
(repeat first verse)





© 2013 L. Ryan

Monday, April 7, 2014

as i crawl beneath the rug, and retune my piano...

I've been avoiding you, Dear Reader.  That's something of a compliment, as the avoidance is based on my assessment of your acumen.

It is no secret, my modus operandi in writing most blog posts.  There are a few topics whose past treatment requires continued treatment:

  • CRPS breakthroughs
  • CRPS in daily life (including humorous leitmotifs about do-it-yourself amputation and the joy of suicide) 
  • Any findings in the case of lost child Lindsey Baum 
  • The reliable turdification of José Ochoa (lately, I've investigated the immense amount of money wasted on him by government grants, but gastrointestinal responses have precluded publication of this research) 
  • The scam CRPS / neuropathy treatment CALMARE / ScramblerTherapy (again, I've a half-written post on the hilarious background of its inventor and his woo-science, dedicated to the creation of a machine that spews electricity like a Fountain of Youth -- never mind the obvious idiocy of mixing water and electricity) 
  • Oh, and should my nausea subside, I am overdue in checking in on where the good Dr. Scott Reuben is malpracticing, and in what way

For a bit, I would regularly rag on Phil McGraw and some of his weirder acolytes, and while that was a gratifying release for simmering undercurrents of sadism, I'm trying to stop feeding that easy-peasy awful part of myself.  Now I just follow their shenanigans when late night efforts at mindfulness and distraction via YouTube cat videos fail.  Besides, one day my vision cleared, and I discovered my gratitude for the Unweird friends made while cavorting with McGraw's Chronic Pain Support Group.

By the way, Dear Reader, you've no need to feign shock at my admission of sadism.  On a good day, it makes me something of a Juvenalian satirist.  On a bad day, okay, I get a slight titillation from asshats getting their due... but not to the extent of paraphilia, or a personality disorder. Ignorance drives me batty and I am daily thankful for my innate, unfailing superiority.

It's also no secret that my navel-gazing can get in the way of what might be decently mediocre pseudo-journalism.  I write more about suffering due to CRPS, osteomyelitis, lupus, and osteonecrosis -- all hilariously related -- than I do my ardent political leanings, or other areas of ardor.  Do I wish my knees were worn from kneeling at some other altar than that of the personal?  Oh, yes!

Referring to your acumen, again, Dear Reader, it's clear that this blog is an attempt at therapy, written in as lively a way as I can pull off so that no one will wander the side halls of detritus.  I am writing my way through the remains of a life, deeply sorry for having wasted it so, and therefore frequently embarrassed by my strung together words, the over-estimation of serendipitous thought caressing circumstance.

There are circumstantial caresses that became blessings -- some fleeting benedictions, some amazingly enduring beatific guffaws. People I've met online, mostly.  Writings I'd never thought to have read had not some virtual friend made of them succulent, enticing fare.

One of those blessings is my friend "Peaches," an actual author, a man of the world, familiar enough with life to inflict suggestions as if it were his prerogative (by virtue of being so old, I tell him.. or dream of telling him, one day... one sadistic, wonderrful day!).

Yes, that's right.  I want to meet Peaches.  As much as I want to meet TW, Carol, Diana, Joyce, Benita, Tom, Betty, Fresca, T, and even some who have wished me ill, but in an inspirational way.

Peaches calls me Irene.  I call him "Peaches" because of a phrase that someone stuck into mine head years ago, in a late afternoon patio conversation at a Telegraph Avenue trattoria.  My memory is muddled, but I believe we trampled over Shakespeare and T. S. Eliot before someone declared someone else, glass raised, "a prince, a peach, a pear."

Since that chilly afternoon, spent over perfect antipasto and ignored obligations, I've found no higher praise to offer other beings than that they were "a prince, a peach, a pear." Roasted peppers and marinated artichoke hearts, spiced meats and bursting tomatoes, there was neither peach nor pear in the offing on our rickety cast iron table, rocking the red wine.  So the phrase is of even more value, its provenance being so wondrously lost.  Sadly, it casts its own restrictions -- I never use it to praise, or shower with abundant love, women deserving such approbation.  It has become a sort of obscure pillow talk, the pillow partners more in tune with its vast smooch galore than with its elusive ancestry or culinary provenance.  The role of the house red, delivered in a series of carafes, probably merits further investigation.

I remember the walk home, to a brand new private apartment on one of Oakland's first streets to cross Telegraph, leaving behind Sather Gate, crossing Bancroft and the cafés, book stores, tables of dangling earrings, poseurs, beggars, travelling to home, paper trash swirling, our awareness of danger waking, coffee our first plan before grading.  Funny, but the guy walking with me never was candidate for prince, or peach, or pear.  A good writer and sometimes great poet, he was a fraud, and the essence of the laudatory phrase lies in the genuine.

So.
Right.
Ahem.

Peaches lives in New York City, the old fart.  He is a faithful friend, but that means, of course, frustration at my "here today, gone tomorrow" nature, a nature unaltered even by friendship or blood relation.  I've been under the radar, or, believe it or not, quite concise, these past few weeks.  Still, Peaches fires off an email every few days.

Like today:

Irene...........
Hi.............

In the dark here.... How're you doing?

P.
Bless his heart, Peaches reached out at a moment when I was navel-gazing, seriously lost, seeing no way out from neurological jokes and jerks, pain bad enough to create tears in a body seriously dehydrated from constant fever.  He just wanted an answer.  I wanted a rescue buoy, garrish orange against the cresting teal.

beware, peaches, i've been avoiding writing anyone.  why?  the proof is in my outdated packets of yeast, my bread that will not rise.  i am in a baguette phase.  i'm also heavily medicated at the moment, which means you should stop reading NOW, content to know that i remain irene. i've been promoted from 100 mcg of fentanyl to 150 mcg patches. the joke is that the pain is stronger but there's just no point in making that known.

but, to answer your concision explicitly:

hey, i am DOIN'.  i am DOIN' (that's southern) the best i can.  

very briefly, last week, fred and i concluded that it was up to each of us whether our respective day would be good or bad.  we crowed and strutted, convinced that no circumstance has the power to inflict a "bad" day.  harrumph -- we don't even know what a bad day IS. complain?  whimper?  moan or groan?  ha!  not us!

that lasted three days and then we took a break.

i'm fine, peaches.  frustrated, sad, guilty, tired -- all of which i shall put aside once the fredster rises from his eight layers of covers to take on the day.  yes, fred is a layer fanatic, something he said he learned about in both brooklyn winters and in the huge temperature variations of the ethiopian desert.

well, there is one thing that sucks.  my eyes are going bad again!  and not in any polite subtle way, either.  i had a brief period of being able to read again and was enjoying the literary send off into sleep, no matter how tedious the novel. we are both working our way through minette walters, a very hit and miss affair. i find her interesting when she lets her inner sociologist sing. when she aims at popular success, she's tedious.
                  
being able to read also meant a complementary tub of plain lowfat yogurt with frozen strawberries. it's become impossible for me to read well without the creamy tang of yogurt and the icy comfort of frozen fruit.

when reading goes, it's a musical bedtime, the lullaby a string of rolling stones' songs -- or, these days, the decemberists and early, easy-breezy, very cheesy brett dennen.  

last night was kind of wonderful, drifting off to phil ochs' "the party," which actually made me think of you... and a few other upper crust sorts, and the cocktail parties you must have both enjoyed and endured.

there's a funny aspect to last night's nocturne, the evocation of monastic hours --  in a completely messed up, annoying way -- beyond the cheapo-cheapo piano, designed to set the teeth on edge.  and then there's phil's voice.  hmm, best i move on, eh? 

some time ago, in asking around about phil ochs' "the party," one of my american lit professors recommended i read... tom wolfe's radical chic & mau-mauing the flak catchers.  

unlike my literati betters -- and that means everyone around me -- i suffered mental origami, a conflation of tom and thomas.  flashes of "golden moments," and so, i have to ask, have you read much tom wolfe?  i realize that the scales tip in favor of look-homeward-ish-ness than anything by the journalist author, who saw himself as a brutally honest zola.  and how many occasions have you had to smile politely at some idjit such as myself, mixing wolfe & wolfe, a heathen playing at americana?

so much happens so quickly in the brain, even a brain seeking sleep.

see? i'm DOIN'.  and while i admire concision, i live for word play... 

"And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano..."

all my best to you and yours, and apologies for ruminating all over your email. it should blot up easily with a paper towel. my last sentence ought to be the first:  how are YOU (and yours), sweet peaches?  

irene

(One hint to how the piano was made even more schmaltzy?  it was a series of plastic toy pianos...)

The Party

The fire-breathing rebels arrive at the party early
Their khaki coats are hung in the closet near the fur
Asking handouts from the ladies, while they criticize the Lords
Boasting of the murder of the very hands that pour
And the victims learn to giggle, for at least they are not bored

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

The hostess is enormous, she fills the room with perfume
She meets the guests and smothers them with greetings.
And she asks, "How are you" and she offers them a drink
The countess of the social grace, who never seems to blink
And she promises to talk to you if you promise not to think

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

The beauty of the hour is blazing in the present
She surrounds herself with those who would surrender
Floating in her flattery, she's a trophy-prize, caressed
Protected by a pretty face, sometimes cursed, sometimes blessed
And she's staring down their desires
While they're staring down her dress

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

The egos shine like light bulbs, so bright you cannot see them
Blind each other blinder than a sandbox
All the fury of an argument, holding back their yawns
A challenge shakes the chandeliers, the selfish swords are drawn
To the loser go the hangups, to the victor go the hangers on

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

They travel to the table, the host is served for supper
And they pass each other down for salt and pepper
And the conversation sparkles as their wits are dipped in wine
Dinosaurs on a diet, on each other they will dine
Then they pick their teeth and they squelch a belch saying
"Darling, you tasted divine"

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

The wallflower is waiting, she hides behind composure, composure
She'd love to dance and prays that no one asks her
Then she steals a glance at lovers while her fingers tease her hair
And she marvels at the confidence of those who hide their fears
Then her eyes are closed as she rides away with a foreign legionnaire

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

Romeo is reeling, counting notches on his thighbone
Searching for one hundred and eleven
And he's charming as a child as he leads you to his web
Seducing queens and gypsy girls in the boudoir of his head
Then he wraps himself with a tablecloth and pretends he is a bed

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

Oh, the party must be over, even the losers are leaving
But just one doubt is nagging at my caustic mind
So I snuck up close behind me and I gave myself a kiss
And I led myself to the mirror to expose what I had missed
There I saw a laughing maniac who was writing songs like this

And my shoulders had to shrug
As I crawled beneath the rug and retuned my piano

-- Phil Ochs




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Monday, October 7, 2013

The Shell Game for Shills: CTTC Has a New CEO

The Shell Game



Good morning, Dear Readers.

Without the least bit of a gloat and nary a reminder of the soul-sucking, money-stealing, totally bogus health claims made by CALMARE/Scrambler Therapy adherents, the "technology" that has kept CTTC (Competitive Technologies, Inc.) in the top spot of my list of CRPS Scams, I come before you with a heavy heart to announce that the robust company stock is for sale today at a steamy rate of .0553 -- that's per share, not the discounted price for the whole snake oil business, you chuckleheads!

As you know, I keep one ear to the ground -- not by choice, of course; it's more adherence to gravity -- and the word is that tomorrow is BOGO Day for CTTC.

On a more serious note, Competitive Technologies, "patent" capitalists, has come up with another filing to submit to the SEC.  I knew they'd get the hang of notifying the SEC of every smarmy, desperate move one day, after all that time of being unable to throw together something as simple as an earnings report equipped with super-glued pasties spinning the rip-off of people in severe and constant pain.  Just as they circle the drain, they master the art of big business!

It has to do with some staffing issues.  Here's the press release version of it:


FAIRFIELD, CT--(Marketwired - Oct 4, 2013) - The Board of Directors of Competitive Technologies, Inc., (OTCQX: CTTC) (CTI), today announced the appointment of Conrad F. Mir as President and chief executive officer, with full responsibility for running the corporation, and as a member of the Board of Directors. Mr. Mir will also serve as interim chief financial officer while the Board of Directors commences a search process to identify a suitable candidate to fill the role on a permanent basis. 
"With Mr. Mir's expertise in the micro-cap biotechnology space, along with his experience turning around distressed biotech companies, CTI has the right leadership in place to execute its corporate reengineering plan and enhance long-term shareholder value," said Peter Brennan, chairman of the Board of Directors of CTI. 
Mr. Mir has been mandated to implement a corporate reengineering plan (Plan), which he designed and presented to the Board of Directors. The Plan reengineers CTI's core business, cuts expenses, develops the wound care and bone technologies, and furthers our flagship Calmare© platform. 
The Board of Directors also announced the acceptance of Carl O'Connell's resignation as CEO. Mr. O'Connell has chosen to pursue other business opportunities, but will remain on the Board of Directors to provide continuity and ensure the Plan's success. He has agreed to serve as a special advisor to CTI in various medical technology capacities, including the ongoing development of Calmare. 
"Carl has a wealth of knowledge in the medical device field and will continue to be an instrumental part of the CTI team through his direction and guidance in the board room," added Mr. Brennan. 
In addition, CTI will not extend its consulting agreement with Johnnie Johnson, chief financial officer and consultant to CTI. The company is indebted to his hard work and wishes him success in future endeavors. 
About Mr. Mir
Mr. Mir has over twenty years of investment banking, financial structuring, and corporate reengineering experience. He has served in various executive management roles and on the Board of Directors of several companies in the biotechnology industry. Most recently, Mr. Mir was CFO of Pressure BioSciences, Inc., a sample preparation company advancing its proprietary pressure cycling technology. Before that, he was chairman and CEO of Genetic Immunity, Inc., a plasmid, DNA company in the HIV space, and was the executive director of Advaxis, Inc., a vaccine company. Over the last five years, he was responsible for raising more than $40 million in growth capital and broadening corporate reach to new investors and current shareholders.
 
Conrad has worked for several investment banks including Sanford C. Bernstein, First Liberty Investment Group, and Nomura Securities International. He holds a BS/BA in Economics and English with special concentrations in Mathematics and Physics from New York University. He is a classically trained pianist and teacher, and a student of the martial arts. He is married with two children, alumni council chairman of Tau Kappa Epsilon fraternity - Tau Alpha chapter (NYU), and a member of NIRI. 
About the Company
Competitive Technologies Inc., (CTI) is a biotechnology company developing and commercializing innovative products and technologies. CTI is the licensed distributor of the non-invasive Calmare® pain therapy medical device, which incorporates the biophysical "Scrambler Therapy"® technology developed to treat neuropathic and cancer-derived pain by Professor Giuseppe Marineo.
[I eliminated the "Forward-Looking Statements" pro forma paragraph because of the dangers it imposed on readers -- a possible choking hazard, a means to the inadvertent snort of hot coffee into sinus cavities, etc.]
The Calmare device is currently being manufactured for sale by GEOMC Co., Ltd. of Seoul, South Korea.
Scrambler Therapy®: www.scramblertherapy.org/english.htm
Calmare®: www.calmarett.com
CTI: www.competitivetech.net
 
Contact:Competitive Technologies, Inc.
Conrad Mir
President and CEO
Email Contact
973.798.8882
 
JV Public Relations
Janet Vasquez
Managing Director
Email Contact
212.645.5498
Feeling duly diligent, I looked into the health of the boat from which Conrad Mir debarked. Pressure BioSciences, Inc and its 12 employees can boast a net profit margin for this year's second quarter of -297.99% , quite the decline from the -278.64% deficit for all of 2012.  They did post an improvement in operating margin, tightening that figure to a satisfying -239.84%.  Remember that old adage:   "If your business sustains a negative operating margin for too long, you might need additional funding"!

Oh, and if you are a neophyte investor, like me, you might want to heed Investipedia's advice about profit margins:
  • This ratio is not useful for companies losing money, since they have no profit.
  • A low profit margin can indicate pricing strategy and/or the impact competition has on margins.
Now, I have to say that Pressure BioSciences, Inc has much more interesting language in its "Forward Looking Statements" section than does poor Competitive Technologies, Inc.  For instance:

Further, given the uncertainty in the capital markets and the current status of the Company’s product development and commercialization activities, there can be no assurance that the Company will secure the additional capital necessary to fund its operations beyond September 2013 on acceptable terms, if at all. 

Not to sully the fine name of Yankee's pitcher Mariano Rivera, I am wondering if we might not hang the moniker of "The Closer" on Mr. Mir. Given that his tenure with Pressure BioSciences began in December 2012 and ended with such a huge leap up the rungs of corporate laddership in September 2013, we might even extend that nickname to another favored by that awesome relief pitcher:  "The Sandman."

Oops!  And "oops" is never a good omen!  I incorrectly calculated the time Mr. Mir spent leading Pressure Biosciences.  He managed to serve as CEO of another biotech endeavor, Genetic Immunity, Inc, in his free time before landing at CTTC.  Genetic Immunity, Inc is a subsidiary of Power of the Dream Ventures, Inc. [O Lord, take me now!] Power of the Dream Ventures, Inc is trading today at a whopping four cents.

Power of the Dream Ventures, Inc., (PDV), incorporated on August 17, 2006, is a holding company focused on technology acquisition and development enabling the delivery of concepts and ready to market products to the international market place. The Company develops, acquire, license or co-develop technologies that originates exclusively in Hungary... As of December 31, 2011, the Company had only realized limited revenues from its discontinued TothTelescope project and had not realized any revenues from other inventions.
The keenest review I could find for the TothTelescope was on a forum for telescope enthusiasts.  Rick said:
"I would be *HIGHLY* (I can't emphasize "HIGHLY" enough) suspect of this scope... The comments I have seen on Astromart and Yahoo BinocularAstronomy about this product echo this....someone even thought the website was meant to be a joke. I'm afraid it is meant to be a scam."

A joke.
A scam.
My, but the world is round, and the bean shuffled seamlessly from one shell to another, confounding even the most keen-eyed players of the game.

At least, in Mr. Mir's past, the sham toys don't seem to be aimed at desperate people living lives of declining quality, full of intense and unrelenting pain.  The pain to which he has limited himself -- until now -- appears to have been the familiar marketplace woe of separating a person from his or her money.

In keeping with my consistent attitude of respect for CTTC and their pseudoscientific, testimonial approach to business, tempered with the ardent compassion of a mature Marquis de Sade, I bid adieu to Carl O'Connell.  He's been the subject of much awe, proving worried parents of college students wrong by audaciously turning a degree in psychology into the fodder needed for growing companies in the related fields of "Neurosurgery, Ophthalmology, Orthopedics-Spine, ENT and Dentistry." You've got to figure Carl will land on his feet.








© 2013 L. Ryan

Friday, October 4, 2013

PART ONE: CRPS Clinical Trials [Open as of October 2013]

As much as I act like a hypoglycemic brat when I rant against such therapies as CALMARE/Scrambler and bet everyone to move carefully into all invasive procedures and implanted devices, into some of the edgier drug therapies... I do understand desperation.  Intimately!

Some people also have no health insurance and a clinical trial may be their sole access to care.  Others have intractable levels of CRPS but are still driven to try and help others, and so join in the studies to further scientific inquiry.  In studies with a healthy cohort used for comparison, friends and family of CRPSers can also play a helpful role in advancing knowledge of CRPS / RSD.

It's been a while since I've done a Clinical Trials update, using data from the U. S. National Institutes of Health.  There are other trials but I tend toward the conservative in these things, as wild as my politics can be.  Ahem.

What a shocker to see as a header on the NIH page:
Due to the lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. 
The next lawmaker (or pseudo-lawmaker) who treats this shutdown as some sort of triviality, think of kids with pediatric cancer who are fighting the clock to stay alive, whose parents are pounding their keyboards searching for options, while these Washington AssHats smugly think this is a political game.

Ahem.

Moving right along.  I used some judicious picking and choosing, as some of the options that resulted from my search didn't relate to a CRPSers' concerns.

Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
ClinicalTrials.gov Identifier:  NCT01392599
Sponsor:  Medical University of Vienna
Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) -- After incision of the skin a subcutaneous area of approximately 16 cm² (2.5 square inches) will be en block removed between dermis and muscle fascia. All prior detected and marked veins in the operating field will be ligated or coagulated precisely.The tissue defect generated by this operation will be closed by a full thickness or a meshed skin graft which arises during the preparation.
Detailed Description:
For 140 years the treatment of Complex Regional Pain Syndromes Type II (CRPS II) has been an unsolved problem. Recent findings in animal models assume that CRPS Type II is maintained by a coupling of newly sprouted sympathetic and sensible fibres. Therapeutic approaches have included conventional pain medication, physical therapy, sympathetic blocks, transcutaneous or spinal cord stimulation, injections or infusion therapies and sympathectomy. Alone or in combination these therapies often yielded unfavorable results. The majority of physicians dealing with CRPS patients are convinced that a surgical treatment of the affected extremity only exacerbates the symptoms, especially its hallmark excruciating pain.
Patients with a CRPS Type II at the upper or the lower limb will be included in the study after ineffective pain therapy for more than 6 months. The most proximal region of pain associated with CRPS can be localized and 2% Lidocain will be injected into that area. If the sympathetic, deep, burning pain can be blocked repeatedly with these injections, the subcutaneous veins in the previously determined area will be surgically removed. This operation should lead to the permanent resolution of symptoms.
A visual analogue scale (VAS), the Nottingham Health Profile (NHP), thermography and physical examinations will be used to evaluate the outcome of the operation.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Contact: Wolfgang Happak, Prof., MD 00431404006980 lukikriechbaumer@hotmail.com
Contact: Lukas K Kriechbaumer, MD 00431404007177 lukas.kriechbaumer@meduniwien.ac.at

Division of Plastic and Reconstructive Surgery, 
Department of Surgery, 
Medical University of Vienna
Vienna, Austria, 1090

Related publications recommended by study investigators:


Two Measures of Tactile Acuity in CRPS Type I Patients
ClinicalTrials.gov Identifier:  NCT01888783
Sponsor:  Ruhr University of Bochum
Objective:  This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
Primary Outcome Measures:
tactile acuity as measured by 2-point-discrimination [ Time Frame: unique measurement of maximal one hour duration ] 
Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given

tactile acuity as measured by the Grating Orientation Task (GOT) [ Time Frame: unique measurement of maximal half an hour duration ] 
Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used
Other Outcome Measures:
Touch threshold for light touch [ Time Frame: unique measurement, duration approx. 5 minutes ] 
Touch thresholds are taken from a set of von Frey filaments (0.25 mN - 512 mN). Touch sensitivity is investigated by using a staircase procedure during which subjects are required to close their eyes and report when they perceive an indentation of the skin on the fingerpad of the index finger. The applied forces are decreased in a stepwise manner until the subject no longer perceives the stimulus (lower boundary) and then increased until the stimulus is perceived again (upper boundary). This procedure is repeated 5 times resulting in 10 values that are averaged to provide the touch threshold.
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Inclusion Criteria:
Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
Patients diagnosed with a neuropathy of the median nerve
Healthy Controls,matched in age and gender to both patient cohorts
Exclusion Criteria:
intolerable hyperalgesia
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders

Contact: Christoph Maier, Prof. Dr. +49 2343023402 Christoph.Maier@rub.de
Head Dep. of Pain Medicine, Ruhr University of Bochum
Contact: Marianne David, Dr. +49 2343023324 Marianne.David@rub.de
Department of Pain Medicine, 
BG Universitätsklinikum Bergmannsheil GmbH
Bochum, Germany, 44789


Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
ClinicalTrials.gov Identifier:  NCT01915329
Sponsor:  Ruhr University of Bochum
The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.
Device: RSS (repetitive sensory stimulation)
Device: SHAM-RSS
Primary Outcome Measures:
static tactile 2-point-discrimination threshold [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ]
Thresholds on the tip of the index finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Threshold are taken from the fit at the distance at which 50% correct answers are given.
Secondary Outcome Measures:
pain intensity [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ] 
Pain intensity is rated by the patient on a 11-point numerical rating scale (NRS). Pain intensity is rated before the start of the 5 day stimulation phase (baseline,pre) and at the end (post, in combination with the other outcome measures). Additionally pain intensity is rated directly before the start of each daily stimulation session and immediately after each session of 45 minute duration.
Other Outcome Measures:
somatosensory evoked potentials [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ] 
Somatosensory evoked potentials after electrical paired pulse median nerve stimulation are recorded. The median nerve is stimulated by innocuous paired electrical pulses conveyed to the nerve by a block electrode placed on the wrist. For correct positioning the subject has to report a prickling sensation in thumb, index and middle finger. Stimulation intensity is choosen to induce a small muscular twich at the thenar muscles. SEP recordings are done with a 3-electrode array. Two electrodes are fixed on the scalp over the left and right somatosensory cortex. The third (reference) electrode is fixed over the midfront. SEP signals get amplified and filtered and digitized in a PC.
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:
Patients diagnosed with CRPS Type I
Exclusion Criteria:
intolerable hyperalgesia
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders
Location: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, NRW, Germany, 44789
Contact: Christoph Maier, M.D., PhD     0049234302 ext 6366     christoph.maier@rub.de    
Contact: Marianne David, Dr.     0049-234-303 ext 3324     Marianne.David@rub.de  

RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
ClinicalTrials.gov Identifier:  NCT01612364
Sponsor:  University of Sao Paulo
Purpose:  This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
Primary Outcome Measures:
Analgesia after block [ Time Frame: 1 month ] 
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Secondary Outcome Measures:
analgesia quality of life [ Time Frame: 1 year ]

Experimental: thoracic sympathetic block //  Sympathetic block of upper limb via thoracic vertebra T3:
Procedure: thoracic sympathetic block
Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
Other Names:
T2-T3 thoracic sympathetic block
T3 sympathetic block
T2-T3 thoracic dorsal sympathetic block
thoracic sympathetic ganglion block
thoracic sympathetic block

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:
Complex regional pain syndrome (IASP, 1994) involving an upper limb;
Pain scores in excess of five visual analog scale (VAS);
Poor outcome to treatment (less than 50% reduction in VAS scores) 
Exclusion Criteria:
History of severe brain injury, epilepsy and stroke
Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
Severe systemic disease
Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
Refusal to participate or not initial adherence to orientations
Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
Contact: Roberto O Rocha, MD 551182668553 contato@drrobertorocha.com.br
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators: University of Sao Paulo; University of Sao Paulo General Hospital

Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
ClinicalTrials.gov Identifier:  NCT01623271
Sponsor:  Massachusetts General Hospital
Purpose: This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.
Primary Outcome Measures:  Visual Analog Scale (VAS) [ Time Frame: 1 year ]
Secondary Outcome Measures:
Functional status [ Time Frame: 1 year ] 
Using the SF-MPQ questionnaire we can determine the subject's health and well-being, especially relating to their daily activities.
Side Effect Profile [ Time Frame: 1 year ] 
Common side effects include: dizziness, drowsiness, headaches, and swelling in extremities. Other side effects may include suicidal behavior or ideation and depression.
Drop Out Rate [ Time Frame: 1 year ]

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:
Subject will be between 18 to 80 years of age.
Subject has not been on Gralise.
Subject has not been on gabapentin for at least one month.
Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment.
Subject has a VAS pain score of 5 or above at the beginning of the study.
Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.
Exclusion Criteria:
Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
Subject has pending litigation related to his/her CRPS I condition.
Subject is pregnant or lactating.
Subject is allergic to gabapentin or Gralise.
Subject has a positive urine (illicit) drug test.
Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Principal Investigator: Jianren Mao, M.D., Ph.D.     
Related Publications Recommended by Study Investigators:
Mao J. Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. Epub 2009 Jul 22. Review.
TMS for CRPS - Pilot Study
ClinicalTrials.gov Identifier:  NCT01926119
Sponsor:  Stanford University
Purpose:  The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.
Primary Outcome Measures:
Change in pain [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up compared to baseline ] 
Secondary Outcome Measures:
Change in motor function and coordination [ Time Frame: End of 5-day treatment series and at 1-week follow-up relative to baseline ] 
As assessed by functional capacity exam and physical exam
Change in sensory perception [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Change in vasomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Change in sudomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Trophic changes [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Change in motor strength and joint range of motion [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline ]
Experimental: TMS Intervention - TBS followed by High Frequency
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Experimental: TMS Intervention - High frequency stimulation followed by TBS
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of High Frequency stimulation followed by Theta Burst Stimulation

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:
Age 18 or older
Diagnosis of CRPS (complex regional pain syndrome)
Average pain level reported on Numerical Rating Scale meets entry criteria
Ability to perform the experimental task and procedures.
Exclusion Criteria:
MRI contraindication (metal implants or devices, claustrophobia)
TMS Contraindication (eg metal implant or devices near the site of stimulation)
History of epilepsy
History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
Neurologic illness that would interfere with brain integrity
Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
Currently pregnant or planning to become pregnant.
On going legal action or disability claim.
Contact: Sean Mackey, MD, PhD smackey@stanford.edu
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Contact: Rebecca McCue     650-724-2795     snapl@stanford.edu    








© 2013 L. Ryan