Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067197
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-08-12
Brief Title:
Improving Motor Learning in Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modulation of Motor Learning in Chronic Stroke Patients by Transcranial DC Stimulation
Status:
COMPLETED
Status Verified Date:
2008-07-17
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:
No universally successful therapy exists that promotes recovery of motor function after a stroke the main cause of long-term disability among adults
The purpose of this study is to develop strategies to improve recovery of lost motor function It will combine motor skills training with a brain-stimulating technique called transcranial direct current stimulation tDCS
Healthy adult volunteers and adult stroke patients will be enrolled in this study Participants will come to NIH for a clinical and neurological exam and if necessary an MRI magnetic resonance imaging examination Participants will return for 4 sessions each lasting approximately 3 hours The first will be a practice session during which participants will become familiar with the motor skills required of them in this study such as performing finger movements on a keyboard pinching tapping making wrist movements and lifting small items In sessions 2 and 3 participants will perform the motor skills they practiced in session 1 while receiving tDCS During session 4 they will receive tDCS only with no performance of motor skills
During tDCS investigators will place electrodes with a gel on participants heads and pass the tDCS current between these two electrodes tDCS is a painless procedure
Participants will receive up to 420 in compensation for their involvement in this study
The purpose of this study is to develop strategies to improve recovery of lost motor function It will combine motor skills training with a brain-stimulating technique called transcranial direct current stimulation tDCS
Healthy adult volunteers and adult stroke patients will be enrolled in this study Participants will come to NIH for a clinical and neurological exam and if necessary an MRI magnetic resonance imaging examination Participants will return for 4 sessions each lasting approximately 3 hours The first will be a practice session during which participants will become familiar with the motor skills required of them in this study such as performing finger movements on a keyboard pinching tapping making wrist movements and lifting small items In sessions 2 and 3 participants will perform the motor skills they practiced in session 1 while receiving tDCS During session 4 they will receive tDCS only with no performance of motor skills
During tDCS investigators will place electrodes with a gel on participants heads and pass the tDCS current between these two electrodes tDCS is a painless procedure
Participants will receive up to 420 in compensation for their involvement in this study
Detailed Description:
There is no universally accepted strategy to promote recovery of motor function after chronic stroke the main cause of long-term disability among adults It is desirable to develop strategies to accelerate motor learning in this patient group Previous studies in healthy volunteers demonstrated that cortical stimulation in association with training leads to improvements of motor learning and use-dependent plasticity The purpose of this protocol is to apply a painless stimulation technique to the motor cortex of the affected hemisphere of patients with subcortical stroke transcranial DC stimulation tDCS to test the hypothesis that tDCS of the motor cortex of the affected hemisphere in association with motor training will improve motor learning of a finger sequence in the paretic hand
Furthermore recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere This abnormality might adversely influence motor recovery Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere to test the hypothesis that reduction of the inhibitory influence of the unaffected hemisphere over the affected in association with motor training will improve motor learning
This technique has been so far applied in several hundred subjects worldwide in the absence of undesirable side effects reported to date
We plan to study patients with chronic strokes and healthy age- and gender matched normal volunteers Primary outcome measure will be the number of correct keyboard piano sequences played in a specific time-period 30 seconds Secondary outcome measures are speed of tapping with only one finger simple reaction times pinch force and a functional measure of activities of daily life ADL Jebsen-Tailor-Test To better understand the mechanisms underlying the proposed behavioral gains we will use TMS to identify changes in corticomotor excitability
Furthermore recent studies have demonstrated that the unaffected hemisphere exerts abnormally high inhibitory influence over the affected hemisphere This abnormality might adversely influence motor recovery Therefore a further purpose of the study is to apply tDCS to the unaffected hemisphere to test the hypothesis that reduction of the inhibitory influence of the unaffected hemisphere over the affected in association with motor training will improve motor learning
This technique has been so far applied in several hundred subjects worldwide in the absence of undesirable side effects reported to date
We plan to study patients with chronic strokes and healthy age- and gender matched normal volunteers Primary outcome measure will be the number of correct keyboard piano sequences played in a specific time-period 30 seconds Secondary outcome measures are speed of tapping with only one finger simple reaction times pinch force and a functional measure of activities of daily life ADL Jebsen-Tailor-Test To better understand the mechanisms underlying the proposed behavioral gains we will use TMS to identify changes in corticomotor excitability
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-0267 | None | None | None |