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 head, or transcranial electrical polarization (TEP) has been done for many years with numerous effects described in healthy subjects and mentally diseased patients. Recently, it has been shown by objective means, in controlled experiments, that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans.

Phase
Phase II

Further Study Details: 

Expected Total Enrollment:  40

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 head, or transcranial electrical polarization (TEP) has been done for many years with numerous effects described in healthy subjects and mentally diseased patients. Recently, it has been shown by objective means, in controlled experiments, that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans.

Genders Eligible for Study:  Both

Criteria

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 tricyclic antidepressants or 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.

Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  050122; 05-N-0122
Record last reviewed:  March 14, 2005
Last Updated:  March 29, 2005
Record first received:  March 29, 2005
ClinicalTrials.gov Identifier:  NCT00106782
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08