Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050128
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-11-21
Brief Title:
Preliminary Study of Transcranial Magnetic Stimulation for Stroke Rehabilitation
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation in Chronic Stroke Patients Dose Effect on Motor Cortex Excitability Motor Performance and Safety Using Different Stimulation Parameters
Status:
COMPLETED
Status Verified Date:
2007-10-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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
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
Detailed Description:
Stroke survivors are often left with permanent physical and mental disabilities that create a major social and economic burden Many of these patients receive different therapies in an attempt to improve their independence and quality of life However most of the current strategies are focused on the acute stage after stroke and are of limited influence in improving stroke outcome One of the main problems of patients who have suffered a stroke is the difficulty in appropriately using the hand contralateral to the lesioned hemisphere to date we have no successful means to improve the hand function in chronic stages of stroke This protocol attempts to address this problem
A promising technique is repetitive transcranial magnetic stimulation rTMS that so far has produced some effects on motor function on other movement disorders like Parkinsons disease PD We hypothesize that rTMS will have a beneficial effect on motor function in chronic stroke patients Specifically we propose to look at the effect of 20 and 25 Hz stimulation since these types of stimulation have been shown to increase the excitability of the cerebral cortex
The purpose of this protocol is to investigate the effect of repetitive transcranial stimulation rTMS on the motor cortex of chronic stroke patients and motor function Four different stimulation parameters within the limits of current safety guidelines will be used We plan to determine 1 which rTMS stimulation parameters induce more cortex excitability 2 whether there is any improvement of hand motor function after rTMS and 3 if the applied stimulation parameters are safe in chronic stroke patients The optimal parameters will be subsequently proposed for use in an experimental protocol for rehabilitation
A promising technique is repetitive transcranial magnetic stimulation rTMS that so far has produced some effects on motor function on other movement disorders like Parkinsons disease PD We hypothesize that rTMS will have a beneficial effect on motor function in chronic stroke patients Specifically we propose to look at the effect of 20 and 25 Hz stimulation since these types of stimulation have been shown to increase the excitability of the cerebral cortex
The purpose of this protocol is to investigate the effect of repetitive transcranial stimulation rTMS on the motor cortex of chronic stroke patients and motor function Four different stimulation parameters within the limits of current safety guidelines will be used We plan to determine 1 which rTMS stimulation parameters induce more cortex excitability 2 whether there is any improvement of hand motor function after rTMS and 3 if the applied stimulation parameters are safe in chronic stroke patients The optimal parameters will be subsequently proposed for use in an experimental protocol for rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0049 | None | None | None |