Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110175
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-05-03
Brief Title:
Motor Performance in Chronic Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Improvement of Motor Performance in Chronic Stroke Patients by Combined Transcranial DC Stimulation and Somatosensory Stimulation
Status:
COMPLETED
Status Verified Date:
2008-03-27
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 determine in stroke patients whether stimulation of the injured side of the brain combined with stimulation of the weak hand can temporarily improve motor function of the paralyzed hand It will also examine whether stimulation of the healthy side of the brain combined with stimulation of the weak hand can temporarily improve motor function in the paralyzed hand
Healthy adult volunteers and adults who have had a stroke more than 3 months before entering the study may be eligible to participate Candidates are screened with a physical and neurological examination Stroke patients also have magnetic resonance imaging MRI a test that uses a strong magnetic field and radio waves to obtain images of the brain
Participants perform several tasks described below in a practice session and then during five more sessions on separate days They perform the tasks before and after undergoing transcranial direct current stimulation tDCS plus electrical stimulation ES and during a procedure that involves sham stimulation For tDCS small rubber electrodes are soaked with water and taped to the subjects head one above the eye and the other on the back of the head The current passes between the two electrodes For ES two pairs of electrodes are attached to the subjects wrist with a paste A very short pulse of current is passed between the electrodes creating an electrical field that stimulates the brain For the sham stimulation the electrodes are similarly placed but there is no stimulation The tasks are
Jebsen-Taylor test Subjects write lift small common objects like paper clips and perform activities like turning pages stacking checkers or lifting large objects They do these tasks as fast as possible
Pinch force Subjects press a wedged instrument between their thumb and index finger as hard as they can There are several trials every 10 seconds
Speed tapping Subjects press a key on a keyboard as quickly as possible for 10 seconds
Simple reaction time task Subjects perform a quick wrist movement as quickly as possible in response to a go signal presented on a computer monitor Muscle activity in the forearm is recorded using electrodes
Motor sequence learningLearning a finger movement sequence Subjects practice a finger movement exercise on a keyboard by pressing keys that correspond to a number displayed on a video screen
Visual analog scales Subjects complete three questionnaires about their attention fatigue and mood
Sensory monitoring Subjects are blindfolded and asked to judge the difference in various sensations such as the feel of plastic domes with gratings vibration or a plastic hair applied to their fingertip
Scoring MRC scale The muscle strength of the subjects hands is measured
Fugl-Meyer scale The subjects ability to move his or her limbs is measured
Mini-mental state examination The subjects mental ability is measured briefly
Handedness questionnaire The subjects dominant hand is determined
Participants also undergo transcranial magnetic stimulation TMS and electromyography EMG before during and after these activities For TMS a wire coil is held on the scalp A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The effect of TMS on the muscles is detected with small electrodes taped to the skin of the arms or legs EMG measures the electrical activity of the muscles For this test small electrodes are taped to the skin over the muscle
Healthy adult volunteers and adults who have had a stroke more than 3 months before entering the study may be eligible to participate Candidates are screened with a physical and neurological examination Stroke patients also have magnetic resonance imaging MRI a test that uses a strong magnetic field and radio waves to obtain images of the brain
Participants perform several tasks described below in a practice session and then during five more sessions on separate days They perform the tasks before and after undergoing transcranial direct current stimulation tDCS plus electrical stimulation ES and during a procedure that involves sham stimulation For tDCS small rubber electrodes are soaked with water and taped to the subjects head one above the eye and the other on the back of the head The current passes between the two electrodes For ES two pairs of electrodes are attached to the subjects wrist with a paste A very short pulse of current is passed between the electrodes creating an electrical field that stimulates the brain For the sham stimulation the electrodes are similarly placed but there is no stimulation The tasks are
Jebsen-Taylor test Subjects write lift small common objects like paper clips and perform activities like turning pages stacking checkers or lifting large objects They do these tasks as fast as possible
Pinch force Subjects press a wedged instrument between their thumb and index finger as hard as they can There are several trials every 10 seconds
Speed tapping Subjects press a key on a keyboard as quickly as possible for 10 seconds
Simple reaction time task Subjects perform a quick wrist movement as quickly as possible in response to a go signal presented on a computer monitor Muscle activity in the forearm is recorded using electrodes
Motor sequence learningLearning a finger movement sequence Subjects practice a finger movement exercise on a keyboard by pressing keys that correspond to a number displayed on a video screen
Visual analog scales Subjects complete three questionnaires about their attention fatigue and mood
Sensory monitoring Subjects are blindfolded and asked to judge the difference in various sensations such as the feel of plastic domes with gratings vibration or a plastic hair applied to their fingertip
Scoring MRC scale The muscle strength of the subjects hands is measured
Fugl-Meyer scale The subjects ability to move his or her limbs is measured
Mini-mental state examination The subjects mental ability is measured briefly
Handedness questionnaire The subjects dominant hand is determined
Participants also undergo transcranial magnetic stimulation TMS and electromyography EMG before during and after these activities For TMS a wire coil is held on the scalp A brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The effect of TMS on the muscles is detected with small electrodes taped to the skin of the arms or legs EMG measures the electrical activity of the muscles For this test small electrodes are taped to the skin over the muscle
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 improve motor function in stroke patients Recently a study in stroke patients demonstrated that transcranial direct current cortical stimulation tDCS in association with motor training leads to improvements of performance and motor learning Similarly somatosensory stimulation peripheral nerve stimulation PNS of the paretic hand in stroke patients results in improvement of performance and motor learning Celnik unpublished data
Objective
The purpose of this protocol is to apply tDCS to the motor cortex of the affected hemisphere tDCS affected in combination with PNS of the paretic hand of patients with chronic stroke to test the hypothesis that combined tDCS affected with PNS will lead to more prominent improvement in motor performance of functional relevant tasks in the paretic hand relative to either intervention alone
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 tDCS unaffected to test the hypothesis that down regulation of activity in the intact hemisphere in combination with PNS of the affected hemisphere will elicit more prominent improvement in functional relevant tasks than either intervention alone
Study population
We plan to study patients with chronic strokes and healthy age gender and hand dominance matched volunteers
Design
To test the hypothesis each subject will participate in 13 sessions in a double blind design The order that patients and controls will receive the interventions will be randomized
Outcome measures
Primary outcome measure will be the total time to complete functional relevant tasks of the hand Jebsen-Tailor-Test JTT Secondary outcomes are tapping speed with one finger simple reaction times SRT pinch force and number of correct keyboard piano sequences played in 30sec with the paretic hand To better understand the mechanisms underlying the proposed behavioral gains we will use transcranial magnetic stimulation TMS to identify corticomotor excitability changes
Objective
The purpose of this protocol is to apply tDCS to the motor cortex of the affected hemisphere tDCS affected in combination with PNS of the paretic hand of patients with chronic stroke to test the hypothesis that combined tDCS affected with PNS will lead to more prominent improvement in motor performance of functional relevant tasks in the paretic hand relative to either intervention alone
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 tDCS unaffected to test the hypothesis that down regulation of activity in the intact hemisphere in combination with PNS of the affected hemisphere will elicit more prominent improvement in functional relevant tasks than either intervention alone
Study population
We plan to study patients with chronic strokes and healthy age gender and hand dominance matched volunteers
Design
To test the hypothesis each subject will participate in 13 sessions in a double blind design The order that patients and controls will receive the interventions will be randomized
Outcome measures
Primary outcome measure will be the total time to complete functional relevant tasks of the hand Jebsen-Tailor-Test JTT Secondary outcomes are tapping speed with one finger simple reaction times SRT pinch force and number of correct keyboard piano sequences played in 30sec with the paretic hand To better understand the mechanisms underlying the proposed behavioral gains we will use transcranial magnetic stimulation TMS to identify corticomotor excitability changes
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 |
|---|---|---|---|
| 05-N-0149 | None | None | None |