CompletedPhase 2

Transcranial Electrical Polarization to Treat Focal Hand Dystonia

United States12 participantsStarted 2005-03-18

Plain-language summary

This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. When people with focal hand dystonia make small and repeated movements with their hands, there is extra activity in the part of the brain called the motor cortex. TEP is a method of brain stimulation that slows down the activity of the nerve cells in the motor cortex. This study may help researchers develop new ways to treat focal hand dystonia. People 18 years of age and older with focal hand dystonia may be eligible for this study. Participants have a neurological examination and are randomly assigned to one of two treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts of the brain used for hand movement, and the placebo group receives sham stimulation, which does not affect any area of the brain. There are three TEP/placebo sessions over a period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2 hours. For TEP, sponge electrodes are placed on the scalp and an electrical current is passed through the scalp and skull to the outer part of brain. Before and after each session, participants have a neurological examination, including an evaluation of the rate and severity of their movement problems. For this assessment, participants do a writing test while the electrical activity of their hand muscles is recorded using surface electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel are taped to the skin over the muscles being tested. Patients are followed in the clinic the day after the end of TEP treatment for evaluation of their movement abilities and the effects of therapy, such as improvement of handwriting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Subjects with focal hand dystonia 18 years old or older will be included. EXCLUSION CRITERIA: Exclusion criteria will include the standard exclusions for TEP as well as exclusions specific to this study. We will exclude subjects with: * Any significant medical or psychiatric illness (other than FHD). * Patients with a positive pregnancy test will be excluded because the effects of TEP on the fetus is unknown. A urine sample for pregnancy testing will be obtained prior to the TEP, and on the day of the first TEP session. * History of epilepsy. * Concurrent use of neuroleptic agents. * Any other licit or illicit drugs other that could lower the seizure threshold. * Metal implants. * Who have received botulinum toxin injection within 10 weeks of starting the protocol. * Secondary hand dystonia. * Mentally impaired patients having no capacity to provide their own consent will be excluded from the study because such patients may have difficulty performing the required test. * If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension. * Unable or unwilling to refrain from alcohol for 24 hours prior to study days. Patients may continue taking muscle relaxants, artane and other anticholinergic drugs, L-DOPA and dopamine agonists.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Fahn Dystonia Scale before and after real and placebo TEP course.

Timeframe: 1 week post-TEP

Trial details

NCT IDNCT00106782

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-05-14

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