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CompletedNCT00001663Updated Mar 4, 2008

Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation

A Phase 1 interventional study of Magstim Super Rapid Stimulator in Movement Disorder, Myoclonus and Nervous System Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Movement Disorder
  • Myoclonus
  • Nervous System Disease

Keywords

  • Neurological Disorders
  • Movement Disorders
  • Physiology
  • Noninvasive
  • Brain Stimulation
  • Cortical Myoclonus
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
10 participants

Interventions

  • DeviceMagstim Super Rapid Stimulator
05

Study locations

1 site
  • National Institute of Neurological Disorders and Stroke (NINDS)
    Bethesda, Maryland 20892, United States
06

References and documents

Publications

  • 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. PubMed 1407578 ↗
  • 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. PubMed 8410704 ↗
  • 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. PubMed 1714819 ↗
07

Registry details

Key details

Study ID
NCT00001663
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Nov 4, 1999
Start date
Jan 1997
Completion
Jan 2002
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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