Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation
Primary Purpose
Movement Disorder, Myoclonus, Nervous System Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magstim Super Rapid Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Movement Disorder focused on measuring Neurological Disorders, Movement Disorders, Physiology, Noninvasive, Brain Stimulation, Cortical Myoclonus
Eligibility Criteria
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.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001663
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001663
Brief Title
Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation
Official Title
Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2002
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorder, Myoclonus, Nervous System Disease
Keywords
Neurological Disorders, Movement Disorders, Physiology, Noninvasive, Brain Stimulation, Cortical Myoclonus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Magstim Super Rapid Stimulator
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1407578
Citation
Cantello R, Gianelli M, Civardi C, Mutani R. Magnetic brain stimulation: the silent period after the motor evoked potential. Neurology. 1992 Oct;42(10):1951-9. doi: 10.1212/wnl.42.10.1951.
Results Reference
background
PubMed Identifier
8410704
Citation
Inghilleri M, Berardelli A, Cruccu G, Manfredi M. Silent period evoked by transcranial stimulation of the human cortex and cervicomedullary junction. J Physiol. 1993 Jul;466:521-34.
Results Reference
background
PubMed Identifier
1714819
Citation
Fuhr P, Agostino R, Hallett M. Spinal motor neuron excitability during the silent period after cortical stimulation. Electroencephalogr Clin Neurophysiol. 1991 Aug;81(4):257-62. doi: 10.1016/0168-5597(91)90011-l.
Results Reference
background
Learn more about this trial
Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation
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