Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001663
Collaborator
(none)
10
1
60
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Study Details

Study Description

Brief Summary

Myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the limbs.

The purpose of this study is to determine if stimulation of the brain with magnetic pulses can decrease myoclonus. Researchers believe that this may be possible because in studies on normal volunteers, magnetic stimulation made areas of the brain difficult to activate for several minutes. In addition, early studies on patients with myoclonus have shown magnetic stimulation to be effective at decreasing involuntary movements.

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain and spinal cord related to motor activity (motor cortex and corticospinal tract). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and off the electrical current. The changing magnetic field produces weak electrical currents in the brain near the coil. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.

Researchers plan to use rTMS for 10 days on patients participating in the study. The 10 day period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of placebo "ineffective" stimulation. At the end of the 10 day period, if the results show that rTMS was beneficial, patients may undergo an additional 5 days of active rTMS.

Condition or Disease Intervention/Treatment Phase
  • Device: Magstim Super Rapid Stimulator
Phase 1

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) at frequencies in the single Hz range causes a decrease in the excitability of the primary motor cortex and there is preliminary evidence that it can suppress abnormal excess cortical activity. We plan to test 1 Hz rTMS as treatment for cortical myoclonus.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation
Study Start Date :
Jan 1, 1997
Study Completion Date :
Jan 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Age 5 to 90 with severe cortical myoclonus.

    No intracranial metal hardware (excluding dental fillings), pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or increased intracranial pressure.

    Subject must not be pregnant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00001663
    Other Study ID Numbers:
    • 970053
    • 97-N-0053
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Mar 4, 2008
    Last Verified:
    Jan 1, 2002

    Study Results

    No Results Posted as of Mar 4, 2008