Tuesday, July 28, 2009

CRPS Clinical Trials


I haven't posted an update of open CRPS clinical trials in a good while. Sorry about that, and allow me to make rapid amends:

1. Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome (CRPS) Vanderbilt University

To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant. If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS.

2. Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study) Study at University of Munich.

3. Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS). Pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (CRPS). Most CRPS patients gain little to no relief from current painkillers. The purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with CRPS. Study at McGill University, Canada.

4. Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I) THIS STUDY IS NOT *YET* OPEN -- Maastricht University Medical Center in the Netherlands

5. Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS. Responsible Party: Drexel University College of Medicine (Dr. Robert J. Schwartzman, MD)

6. Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1) (PEPTOC) THIS STUDY IS NOT *YET* OPEN. Radboud Univ. in the Netherlands

7. Association Between Focal Dystonia and Complex Regional Pain Syndrome an NIH study:
This study will investigate differences among people with focal dystonia (FD), complex regional pain syndrome (CRPS) and people who have both conditions to learn more about the cause of both disorders. Participants undergo the following procedures in five visits:

Electroencephalography (EEG). Electrodes (metal discs) are placed on the scalp with an electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while the subject lies quietly and sensory stimulation is applied to the thumb or finger.
Magnetic resonance imaging (MRI). This test uses a magnetic field and radio waves to obtain images of body tissues and organs. The patient lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 minutes, during which time the patient will be asked to lie still for up to 15 minutes at a time.
Transcranial magnetic stimulation (TMS). An insulated wire coil is placed on the scalp and a brief electrical current is passed through the coil. The current induces a magnetic field that stimulates the brain. There may be a pulling sensation on the skin under the coil and a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to keep their hands relaxed or to contract certain muscles.
Peripheral electrical stimulation. In two experiments, TMS is combined with peripheral electrical stimulation, similar to what is used in nerve conduction studies, to the median nerve at the wrist. There may be muscle twitching.
Surface electromyography. For TMS tests and peripheral electrical stimulation, electrodes are filled with a conductive gel and taped to the skin to record the electrical activity of three muscles on the right hand.
Needle EMG. A needle is inserted into a muscle to record the electrical activity.
Nerve conduction studies. A probe is placed on the skin to deliver a small electrical stimulus, and wires are taped to the skin record the nerve impulses. These studies measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscles.
Skin biopsy. Two sites are biopsied. A local anesthetic is given to numb the area and a 1/4-inch piece of skin is removed with a special tool.
JVP domes. Subjects are tested for their ability to discriminate sensory stimuli in the affected region and on the other side of it. They are asked to discriminate between stamps with grooves of different widths that are applied to the hands or feet.

8. The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy This study is not yet open for participant recruitment. Soroka University Medical Center in Beersheba, Israel

9. A Study of the Effect of Lenalidomide on Complex Regional Pain Syndrome Type 1
Mayo Clinic -- Rochester, Minnesota
More on Lenalidomide here.

10. Evoked Fields After Median and Ulnar Stimulation
Medical Center Alkmaar
Rudolf Magnus Institute – University of Utrecht
Technical University of Twente
VU University of Amsterdam
Dept. of Clinical Neurophysiology - VU University Hospital Amsterdam
Human Brain Mapping and Cortical Imaging Laboratory, Centre for Sensory – Motor Interaction, Aalborg University
Intervention = Evoked fields before and after a local block (Xylocaine)

11. Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study)
McMaster University, Ontario, Canada

12. The Efficacy of Motor Cortex Stimulation for Pain Control
The objective is to determine if motor cortex stimulation works for the following conditions:
Deafferentation facial pain,
Upper extremity complex regional pain syndrome (CRPS) and
Brachial plexus avulsion or phantom limb pain.
Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system.

13. Neurotropin to Treat Chronic Neuropathic Pain An NINR study, Bethesda, Maryland

14. Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
An NINR study; No treatment is offered under this protocol.

15. Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)
The purpose of this study is to examine the short and long-term benefits of implementing early advanced regional anesthesia techniques for pain control, such as reducing pain disability and the incidence and severity of mental health disorders, following major traumatic injuries to extremities encountered during combat in the Iraqi/Afghanistan war. Dept. of Veterans Affairs/Walter Reed

16. Susceptibility to Chronic Post-Traumatic Extremity Pain The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will be assessed stratifying the patients based on the individual categories of trauma or elective surgery. William Beaumont Hospitals, Michigan

17. N/A Cardiac Rehabilitation Programs = (CRPs)!

18. N/A

19. Cerebrospinal Fluid Repository (CSF) The purpose of a CSF repository is to collect samples of spinal fluid from controls and patients with neurologic disorders including but not exclusively ALS, Dementia, CRPS, neuropathies, and other neuromuscular diseases. This CSF repository will allow the use of CSF in biochemical studies of various neurologic diseases. It would also provide a supply of the necessary normal and disease control patients. CSF would be obtained from patients who are undergoing spinal taps for other reasons including diagnosis, treatment, or participation in clinical trials. We are proposing to collect an additional <>

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