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NCT00050128 · ClinicalTrials.gov registry record · Phase 1

Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation

A Phase 1 study of Cerebrovascular Accident, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT00050128 is a Phase 1 study of Cerebrovascular Accident that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 15 participants, below the 517-participant average among 26 other Cerebrovascular Accident trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00050128, a Phase 1 study of Cerebrovascular Accident, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabilitation study and confirm the safety of the procedure at these settings. Some previous studies using TMS to treat movement disorders such as Parkinson's disease have shown improvement in motor function; others have not. The results of this study may provide information to help researchers design better rehabilitation treatments after stroke. Stroke patients with residual arm function and no history of seizures may be eligible for this study. The stroke must have occurred at least 6 months before entry into the study and must have affected only one side of the brain. For the TMS procedure, subjects are seated in a comfortable chair with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the outer part of the brain, called the cortex. This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may affect movements or reflexes. Subjects are asked to make movements, do simple tasks, or tense muscles. Metal electrodes are taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. The testing lasts 2-3 hours.

Conditions Studied

Interventions

  • DEVICE rTMS, Magstim

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2002-11-18
Est. Completion 2007-10-24
Phase Phase 1

What the Registry Record Tells You About NCT00050128

The ClinicalTrials.gov registry entry for NCT00050128 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 517-participant average among 26 other Cerebrovascular Accident trials with a reported enrollment target (97% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cerebrovascular Accident appearing as the primary indexed condition, and to 1 intervention - of which rTMS, Magstim is the first listed.

NCT00050128 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00050128 about?

NCT00050128 is a clinical study titled "Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation". This is a preliminary study to evaluate the possible use of transcranial magnetic stimulation (TMS), together with exercise, for rehabilitation of chronic stroke patients. It will identify the optimum stimulation settings (within the limits of current safety guidelines) to be used in a later rehabil...

What is the current status of trial NCT00050128?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2002-11-18. Estimated completion is 2007-10-24.

What conditions does trial NCT00050128 study?

This clinical trial studies the following conditions: Cerebrovascular Accident.

What interventions are being tested in trial NCT00050128?

The interventions under investigation include: rTMS, Magstim (DEVICE).

Who is sponsoring clinical trial NCT00050128?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00050128 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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