Cerebrovascular AccidentNCT00023569
Electrical Stimulation to Improve Hand Function in Patients With Chronic Stroke
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Sep 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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 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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Keywords
- TMS, Conjoint Movement, Chronic Hemiplegia, Brain Plasticity, Electrical Stimulation, Stroke, CVA
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2001 (estimated)
- Study startSep 2001
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023569
- Sponsor's protocol ID
- 010248
- Other IDs
- 01-N-0248
- Status last verified
- Sep 2003
- First submitted
- 8 Sep 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.
PubMed 1543423Fields RW. Electromyographically triggered electric muscle stimulation for chronic hemiplegia. Arch Phys Med Rehabil. 1987 Jul;68(7):407-14.
PubMed 3496865Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4. doi: 10.1161/01.str.31.6.1360.
PubMed 10835457
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Motor Reorganization in Chronic Stroke Following EMG Triggered NMES Therapy
- ClinicalTrials.gov ID
- NCT00023569
- Acronym / sponsor ID
- 010248
- Conditions
- Cerebrovascular Accident
- Keywords
- TMS, Conjoint Movement, Chronic Hemiplegia, Brain Plasticity, Electrical Stimulation, Stroke, CVA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- Sep 2003
- First posted
- 10 Sep 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1543423Kraft GH, Fitts SS, Hammond MC. Techniques to improve function of the arm and hand in chronic hemiplegia. Arch Phys Med Rehabil. 1992 Mar;73(3):220-7.
- Background: PubMed 3496865Fields RW. Electromyographically triggered electric muscle stimulation for chronic hemiplegia. Arch Phys Med Rehabil. 1987 Jul;68(7):407-14.
- Background: PubMed 10835457Cauraugh J, Light K, Kim S, Thigpen M, Behrman A. Chronic motor dysfunction after stroke: recovering wrist and finger extension by electromyography-triggered neuromuscular stimulation. Stroke. 2000 Jun;31(6):1360-4. doi: 10.1161/01.str.31.6.1360.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023569, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.