Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021710
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-08-02
Brief Title:
Motor Learning in Stroke Patients and Healthy Volunteers
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Motor Learning Behavioral and Physiologic Studies in Normal Volunteers and Stroke Patients
Status:
COMPLETED
Status Verified Date:
2005-06
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 study will try to elucidate learning processes associated with motor training in the weak arm of stroke patients compared with healthy controls Results from previous clinical trials indicate that training may enhance motor function in healthy volunteers and perhaps also in stroke patients even more than 1 year after the stroke Normal healthy volunteers and stroke patients 18 years of age and older may be eligible for this study
Study subjects will have a physical examination and participate in 6 additional clinic visits-training and testing sessions on study days 1 2 3 4 and 5 and a final testing session on day 12 During these sessions they will perform a series of motor tasks including writing picking up objects turning cards stacking checkers and moving cans which will be timed and videotaped Each session will be divided into blocks of 10 trials for each task separated by 2-minute rest periods
Before and after training on days 1 2 5 and 12 subjects will have transcranial magnetic stimulation TMS to determine brain changes associated with learning a motor task For this procedure the patient is seated in a comfortable chair and an insulated wire coil is placed on the scalp or skin A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain These pulses generate very small electrical currents in the brain cortex briefly disrupting the function of the brain cells in the stimulated area The stimulation may cause muscle twitching or tingling in the scalp face or limb During the stimulation the subject may be asked to slightly tense certain muscles or perform other simple actions
Electrical nerve stimulation and electromyography will be done to record muscle responses to stimulation A nerve is stimulated by placing wires on the skin over the nerve and passing a brief electrical current between the wires Electromyography involves taping metal electrodes to the skin over the muscle
Before and after each session subjects muscle strength will be tested with a pinch gauge They will also be asked to make a mark on a line drawn on paper to rate their test performance and levels of attentiveness and fatigue
Study subjects will have a physical examination and participate in 6 additional clinic visits-training and testing sessions on study days 1 2 3 4 and 5 and a final testing session on day 12 During these sessions they will perform a series of motor tasks including writing picking up objects turning cards stacking checkers and moving cans which will be timed and videotaped Each session will be divided into blocks of 10 trials for each task separated by 2-minute rest periods
Before and after training on days 1 2 5 and 12 subjects will have transcranial magnetic stimulation TMS to determine brain changes associated with learning a motor task For this procedure the patient is seated in a comfortable chair and an insulated wire coil is placed on the scalp or skin A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain These pulses generate very small electrical currents in the brain cortex briefly disrupting the function of the brain cells in the stimulated area The stimulation may cause muscle twitching or tingling in the scalp face or limb During the stimulation the subject may be asked to slightly tense certain muscles or perform other simple actions
Electrical nerve stimulation and electromyography will be done to record muscle responses to stimulation A nerve is stimulated by placing wires on the skin over the nerve and passing a brief electrical current between the wires Electromyography involves taping metal electrodes to the skin over the muscle
Before and after each session subjects muscle strength will be tested with a pinch gauge They will also be asked to make a mark on a line drawn on paper to rate their test performance and levels of attentiveness and fatigue
Detailed Description:
The purpose of this protocol is to characterize dynamics of motor learning over a 5-day period in chronic stroke patients relative to healthy age-matched controls Motor learning will be assessed by improvements in the Jebsen-Taylor test a validated tool widely used in rehabilitation that measures upper extremity function Additionally we intend to evaluate changes in the excitability of the primary motor cortex associated with learning using transcranial magnetic stimulation
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 |
|---|---|---|---|
| 01-N-0220 | None | None | None |