Magnetic Stimulation of the Human Nervous System

Healthy Clinical Trial

Official title:

Stimulation of the Human Central and Peripheral Nervous System With a Magnetic Stimulator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001780
• Other study ID #: 980065
• Secondary ID: 98-N-0065
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: February 1998
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Demyelinating Disease
• Demyelinating Diseases
• Healthy
• Lysosomal Storage Disease
• Lysosomal Storage Diseases
• Motor Neuron Disease
• Movement Disorder
• Movement Disorders

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Eisen AA, Shtybel W. AAEM minimonograph #35: Clinical experience with transcranial magnetic stimulation. Muscle Nerve. 1990 Nov;13(11):995-1011. — View Citation

Müller K, Hömberg 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. — View 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. — View Citation