Electrical Stimulation to Improve Hand Function in Patients With Chronic Stroke
|First Received Date ICMJE||September 8, 2001|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||September 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00023569 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Electrical Stimulation to Improve Hand Function in Patients With Chronic Stroke|
|Official Title ICMJE||Cortical Motor Reorganization in Chronic Stroke Following EMG Triggered NMES Therapy|
This study will determine whether an electric shock to the forearm can improve hand function in patients with chronic stroke and, if so, whether the improvement is related to brain reorganization. Some studies indicate that electromyography-triggered neuromuscular electrical stimulation (EMG-triggered NMES) on the forearm improves wrist motor function in patients with chronic stroke. The shock is delivered to the wrist extensor muscle of the forearm, causing greater hand movement than the patient can make on his or her own. The study will determine if the electric shock is more effective given after the patient initiates the hand movement (EMG-triggered NMES) than at times unrelated to patient effort (NMES alone).
Stroke patients with muscle weakness on one side of the body may be eligible for this study. The stroke must have occurred at least 12 months before the patient enters the study. Candidates will have a medical history and physical and neurological examinations.
Participants will be divided randomly into two groups: EMG-triggered NMES, and NMES alone. For EMG-triggered NMES, two electrodes from the NMES machine and two EMG electrodes are placed on the wrist extensor muscle of the forearm. The patient relaxes the hand, then contracts the wrist extensor muscle to produce movement. This movement triggers the NMES to deliver enough electrical stimulation to produce maximum wrist extension. For NMES alone, only the two NMES electrodes are placed on the forearm. The patient relaxes the hand and stimulation is applied at an intensity to produce full wrist extension without any patient effort.
At the first clinic visit, baseline hand function is measured with the following tests:
In addition, transcranial magnetic stimulation (TMS) is done to examine brain activity. For this test, an insulated wire coil is placed on the patient's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, electrical activity of muscles are recorded with a computer or other recording device, using electrodes attached to the skin with tape.
Participants will be instructed in how to use the NMES machine at the first visit. They will be required to practice with the machine at home 30 minutes twice a day every day for 4 weeks, for a total of about 56 sessions. Follow-up evaluations of hand function will be done one day after the first NMES or EGM-triggered NMES task, then after 2 weeks and after 4 weeks of performing the exercise. These evaluations include the tests described above for baseline measurements, plus TMS.
The purpose of this study is to investigate the effect of a newly developed electrical technique, electromyography (EMG) triggered neuromuscular electrical stimulation NMES) known as EMG-Stim., on brain reorganization. Clinically EMG-Stim. is thought to improve a chronic hemiparetic hand [1-3], but its underlying mechanism is poorly understood. We plan to determine: (1) if EMG-Stim. on a chronic hemiparetic hand as a result of stroke enhances improved hand motor function; and (2) whether any clinical improvement is related to brain reorganization.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cerebrovascular Accident|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects with residual arm function who have had a single cortical monohemispheric stroke (documented by CT or MRI) at least 12 months before, with normal visual acuity (with or without glasses).
Subjects with more than one stroke.
Subjects with proprioceptive deficits.
Subjects with cerebellar lesion.
Subjects unable to extend metacarpophalangeal (MP) joints at least 10 degrees.
Subjects unable to extend the wrist 10 degrees.
Subjects with cognitive impairment which might interfere with the understanding of instructions for motor testing (defined as equivalent to a mini-mental state exam score of 20 or less).
Subjects with severe depression, poor motivational capacity, or severe language disturbance.
Subjects with severe uncontrolled medical problems (e.g. cardiovascular disease, active joint deformity of arthritic origin, uncontrolled epilepsy).
Subjects with heart pacemakers.
Subjects with contractures in the hand.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00023569|
|Other Study ID Numbers ICMJE||010248, 01-N-0248|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2003|
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