Clinical Trial: Transcranial Magnetic Stimulation for Focal Hand Dystonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Gamma Frequency Transcranial Magnetic Stimulation in Dystonia

Brief Summary:

Background:

  • The brain has natural electrical rhythms of brain activities. These rhythms may be different in people with movement disorders, such as dystonia (involuntary muscle movement, cramps, or tremors). Understanding these rhythms may provide more information about movement disorders.
  • Focal hand dystonia, also known as "writer's cramp" or "musician's cramp," is a painful condition that affects the hand and arm muscles. Researchers want to use transcranial magnetic stimulation (TMS) to study brain rhythms in people with and without focal hand dystonia.

Objectives:

- To better understand brain rhythms involved in focal hand dystonia.

Eligibility:

  • Individuals between 18 and 70 years of age who are right-handed and have focal hand dystonia.
  • Healthy right-handed volunteers between 18 and 60 years of age.

Design:

  • Participants will be screened with a physical exam and medical history.
  • This study includes two tests: a pilot test and a main test. The pilot test will determine the frequency of TMS that will be used in the main test. Participants may be in one or both tests. Each test requires a single outpatient visit that will last up to 5 hours.
  • Participants will have a base test to see how their muscles respond to TMS. This will look at the electrical activity of the muscles. Participants will have a wire coil held

    Detailed Summary:

    Objectives:

    The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using transcranial magnetic stimulation (TMS). The study may reveal new information about the role of gamma frequency oscillations in cortical facilitation in dystonia patients versus healthy volunteer subjects.

    The findings of this study may also help to determine if abnormal gamma frequency facilitation might become a potential diagnostic tool for dystonia.

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    Study population:

    1. We intend to study 13 healthy volunteers and 13 patients with a diagnosis of focal hand dystonia. Thirteen subjects for each group are needed based on the power analysis, with an additional three added to the requested accrual to account for drop-outs, yielding a maximum of 16 subjects per group. Up to 15 focal hand dystonia patients and 15 healthy volunteers may be involved in the pilot experiment. The pilot study will be stopped when a trend in the data emerges, so the total number of subjects who participate in the pilot study may end up being less than the maximum requested accrual of 15. Subjects in the pilot experiment are eligible to later participate in the main experiment.

    Design:

    The subject will be seated with EMG surface electrodes over the First Dorsal Interosseous (FDI) muscle of each hand monitoring muscle activity. The TMS coil will be placed on the surface of the head and the region of motor cortex corresponding to the respective hand muscle control. The baseline motor evoked potential (MEP) for the FDI muscle will be determined
    Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

    Current Primary Outcome: Motor evoked potential following TMS conditioning versus the baseline MEP amplitude in dystonia patients and healthy subjects. [ Time Frame: 6 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: February 13, 2013
    Date Started: January 23, 2013
    Date Completion: July 5, 2017
    Last Updated: April 20, 2017
    Last Verified: October 11, 2016