Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023569
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-09-08
Brief Title:
Electrical Stimulation to Improve Hand Function in Patients With Chronic Stroke
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cortical Motor Reorganization in Chronic Stroke Following EMG Triggered NMES Therapy
Status:
COMPLETED
Status Verified Date:
2003-09
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 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
Wrist extension - wrist extension is measured with a digital instrument called an accelerometer
Pinch power - grip strength between thumb and index finger is measured with a digital pinch analyzer
Jebsen-Taylor hand function - function is evaluated through activities such as moving a can and lifting a pin
H reflex - Note I could not find a description of this test or its purpose in the consent or the protocol
In addition transcranial magnetic stimulation TMS is done to examine brain activity For this test an insulated wire coil is placed on the patients 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
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
Wrist extension - wrist extension is measured with a digital instrument called an accelerometer
Pinch power - grip strength between thumb and index finger is measured with a digital pinch analyzer
Jebsen-Taylor hand function - function is evaluated through activities such as moving a can and lifting a pin
H reflex - Note I could not find a description of this test or its purpose in the consent or the protocol
In addition transcranial magnetic stimulation TMS is done to examine brain activity For this test an insulated wire coil is placed on the patients 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
Detailed Description:
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 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-0248 | None | None | None |