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Completed

NCT Number: NCT00001663

Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magstim Super Rapid Stimulator

Device

Sponsors and collaborators

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Nih

Registry information

Important dates

Study start
1997
Study completion
2002
First posted
Nov 4, 1999
Registry last updated
Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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