Protocol Number: 08-N-0040

Title:

The Association Between Focal Dystonia (FD) and Complex Regional Pain Syndrome (CRPS)

Number:

08-N-0040

Summary:

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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

PATIENTS WITH FOCAL DYSTONIA (ONLY):

-Age 18 years or older

-Presence of FD and no CRPS

PATIENTS WITH CRPS (ONLY):

-Age 18 years or older

-Presence of CRPS and no FD

PATIENTS WITH DYSTONIA AND CRPS (CRPS + DYSTONIA):

-Age 18 years or older

-Presence of FD and CRPS in the same limb

EXCLUSION CRITERIA:

-Concurrent significant medical, surgical, neurologic or psychiatric condition

-Taking the following medications: anxiolytics, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines

-Taking antidepressants or anticonvulsants needs to be discussed specifically in each patient

-Received botulinum toxin injection within 3 months of starting the protocol

-For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye

-History of seizure disorder

-No known history of hearing loss

-For MRI: Presence of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.

-Pregnancy.

Special Instructions:

Currently Not Provided

Keywords:

Sensory Evoked Potentials (SEPs)

Electromyogram

Transcranial Magnetic Stimulation (TMS)

Complex Regional Pain Syndrome

Focal Hand Dystonia

Recruitment Keyword(s):

Focal Dystonia

Chronic Regional Pain Syndrome

CRPS

Condition(s):

Focal Dystonia

Peripheral Nervous System Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. Review. No abstract available.

Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. Review. No abstract available.

Rothwell JC, Obeso JA, Day BL, Marsden CD. Pathophysiology of dystonias. Adv Neurol. 1983;39:851-63. No abstract available.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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