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Magnetic Stimulation of the Human Nervous System

Primary Purpose

Demyelinating Disease, Healthy, Lysosomal Storage Disease

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Demyelinating Disease focused on measuring Myelopathy, Demyelination, Leukodystrophy, Motor Neuron Disease, Movement Disorders, Normal Volunteer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Adult patients with weakness or motor dysfunction. Children and adolescents with corticospinal tract signs. Normal volunteers, adults. Normal volunteers, children aged 4-17. EXCLUSION CRITERIA: Pregnant women. Subjects with implanted devices: pacemakers, medication pumps or defibrillators. Subjects with metal in the cranium except the mouth. Subjects with intracardiac lines. Normal subjects with history of seizures.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001780
Brief Title
Magnetic Stimulation of the Human Nervous System
Official Title
Stimulation of the Human Central and Peripheral Nervous System With a Magnetic Stimulator
Study Type
Observational

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique to gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, spinal cord and nerve roots). The procedure is conducted by transmitting a magnetic signal into the brain to stimulate an area of the body. Electrodes (small pieces of metal taped to areas of the body) are used in order to measure electrical activity. A magnetic signal is sent from a metal instrument held close to the patient's head, to an area of the brain responsible for motor activity of a certain area of the body. The electrodes pick up and record the electrical activity in the muscles. This study will employ the use of TMS to diagnose neurological disorders that affect the motor cortex or the corticospinal tract. Normal subjects are sometimes studied to investigate normal activity of the nervous system and to train doctors in clinical neurophysiology and electrodiagnostic medicine at the National Institutes of Health (NIH).
Detailed Description
This protocol outlines the use of magnetic stimulation as a diagnostic tool in patients with suspected dysfunction of central motor pathways or nerve roots and as a tool to localize and characterize suspected corticospinal abnormalities in neurologic disorders and systemic disorders with neurological manifestations. The protocol is intended for clinical use. Transcranial magnetic stimulation has been used for diagnosis of neurologic disorders since 1987. The principles of magnetic stimulation and its use for diagnosis are described in current textbooks of clinical neurophysiology as a routine procedure and should be included in the training program for fellows in clinical neurophysiology and electrodiagnostic medicine at NIH. The magnetic stimuli are to be given as single or paired pulses at repetition rates less than 1 per second.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Demyelinating Disease, Healthy, Lysosomal Storage Disease, Motor Neuron Disease, Movement Disorder
Keywords
Myelopathy, Demyelination, Leukodystrophy, Motor Neuron Disease, Movement Disorders, Normal Volunteer

7. Study Design

Enrollment
450 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Adult patients with weakness or motor dysfunction. Children and adolescents with corticospinal tract signs. Normal volunteers, adults. Normal volunteers, children aged 4-17. EXCLUSION CRITERIA: Pregnant women. Subjects with implanted devices: pacemakers, medication pumps or defibrillators. Subjects with metal in the cranium except the mouth. Subjects with intracardiac lines. Normal subjects with history of seizures.
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
2233862
Citation
Eisen AA, Shtybel W. AAEM minimonograph #35: Clinical experience with transcranial magnetic stimulation. Muscle Nerve. 1990 Nov;13(11):995-1011. doi: 10.1002/mus.880131102.
Results Reference
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PubMed Identifier
8740220
Citation
Wassermann EM, Samii A, Mercuri B, Ikoma K, Oddo D, Grill SE, Hallett M. Responses to paired transcranial magnetic stimuli in resting, active, and recently activated muscles. Exp Brain Res. 1996 Apr;109(1):158-63. doi: 10.1007/BF00228638.
Results Reference
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PubMed Identifier
1705221
Citation
Muller K, Homberg V, Lenard HG. Magnetic stimulation of motor cortex and nerve roots in children. Maturation of cortico-motoneuronal projections. Electroencephalogr Clin Neurophysiol. 1991 Feb;81(1):63-70. doi: 10.1016/0168-5597(91)90105-7.
Results Reference
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Magnetic Stimulation of the Human Nervous System

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