Transcranial Electrical Polarization to Treat Focal Hand Dystonia

NCT00106782 | Completed Phase 2

• 2 other identifiers: 05012205-N-0122
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Dystonia; Focal Hand Dystonia; FHD

Keywords

Electrical; Stimulation; Dystonia; Brain; Focal Hand Dystonia; FHD

Outcome Measures

Primary Outcomes (1)

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

  1 week post-TEP

Study Arms (2)

1

OTHER

Real TEP

Procedure: Transcranial Electrical Polarization (TEP)

2

OTHER

Sham Stimulation

Procedure: Transcranial Electrical Polarization (TEP)

Interventions

Transcranial Electrical Polarization (TEP) PROCEDURE

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with focal hand dystonia 18 years old or older will be included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.

  PMID: 3808255 BACKGROUND

• Antal A, Nitsche MA, Paulus W. External modulation of visual perception in humans. Neuroreport. 2001 Nov 16;12(16):3553-5. doi: 10.1097/00001756-200111160-00036.

  PMID: 11733710 BACKGROUND

• Chen R, Wassermann EM, Canos M, Hallett M. Impaired inhibition in writer's cramp during voluntary muscle activation. Neurology. 1997 Oct;49(4):1054-9. doi: 10.1212/wnl.49.4.1054.

  PMID: 9339689 BACKGROUND

MeSH Terms

Conditions

Dystonia; Dystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 29, 2005
• First Posted: March 30, 2005
• Study Start: March 18, 2005
• Primary Completion: May 14, 2010
• Study Completion: May 14, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-05-14

Locations

US (1)