Status:
COMPLETED
Transcranial Electrical Polarization to Treat Focal Hand Dystonia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Dystonia
Focal Hand Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, muscl...
Detailed Description
Objective: The treatment of focal hand dystonia (FHD) needs further improvement. A deficiency of inhibition was demonstrated in patients with writer's cramp. The passage of weak DC currents across the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 18 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00106782
Start Date
March 18 2005
End Date
May 14 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892