Cerebrovascular AccidentNCT00006414
Hand Exercise and Upper Arm Anesthesia to Improvements Hand Function in Chronic Stroke Patients
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 examine the effectiveness of an experimental treatment to improve hand function in patients who have had a stroke affecting one side of the body. One of the main problems of stroke patients is difficulty using the affected hand. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Mar 2006
- 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
- Twelve hemispheric patients (right or left) with residual arm function who had a single monohemispheric stroke (documented by CT or MRI) at least 12 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.
- They should all be able to perform the training task.
Who cannot join
- Excluded from the study will be: patients with more than one stroke;
- patients with large cortical, cerebellar or brainstem lesions;
- Patients unable to extend metacarpophalangeal (MP) joints at least 10-20 degrees;
- Patients unable to extend the wrist at least 20 degrees;
- Patients with substantially recovered motor function;
- Patients with severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature;
Show all 12Show fewer
- Patients with severe spasticity/pain;
- Patients with bilateral motor problems;
- Patients with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less);
- Patients severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others);
- Patients with respiratory failure;
- Patients with friable plaques (class D disease) or a stenosis exceeding 70% in the internal carotid artery ipsilateral to the side of paresis (as assessed with ultrasonography).
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: Improvements of Hand Function in Chronic Stroke Related to Upper Arm Anesthesia
This study will examine the effectiveness of an experimental treatment to improve hand function in patients who have had a stroke affecting one side of the body. One of the main problems of stroke patients is difficulty using the affected hand. Most treatments focus on acute (early) intervention, although special exercises may help some chronic patients. Previous studies have indicated that combining hand exercises with anesthesia (blocking motor and sensory function) of the upper arm may improve hand movement in stroke patients, even in the chronic state. This study will examine whether the exercise plus anesthesia treatment is more beneficial for these patients over the long-term than exercise alone.
Patients 18 years or older who are at least 12 months post stroke, which has affected only one side of the body, may be eligible for this study. Candidates will have a medical history and physical and neurological examinations.
Read more
Participants will be randomly divided into two groups: one will practice hand exercises without upper arm anesthesia and the other will exercise with anesthesia. All patients will perform two consecutive sessions of 30-minute pinch practice-forceful pinching of the thumb and index finger. Patients in the anesthesia group will have the anesthetic injected in the lower neck. Enough anesthetic will be administered to block motor and sensory function in the shoulder and upper arm, while maintaining as much function as possible in the forearm and hand.
All patients will also have transcranial magnetic stimulation (TMS) testing. For this procedure, a very brief electrical current is passed through an insulated wire coil placed on the head, producing a magnetic pulse. The pulse travels through the scalp and skull and causes small electrical currents in the outer part of the brain. During the study, the patient will be asked to make movements, do simple tasks, or tense muscles, while the electrical activity of the muscles is recorded.
Patients will have four sessions at 3-week intervals and three follow-up sessions at 3 weeks, 9 weeks and 24 weeks after the testing. Follow-up evaluations will include pinch power testing, TMS, sensory function test and hand function measurement.
Read the detailed description
The purpose of this protocol is to enhance our understanding of the effect of regional anesthesia of the proximal arm paired with practice on motor recovery after stroke. We plan to determine; 1) if regional anesthesia of the proximal arm (above the elbow level) paired with practice in chronic disabled stroke patients enhances an improvement of the hand motor function in addition to motor power; 2) if further enhancement of motor improvement can be achieved by repetitive trials of this intervention; and 3) how long this effect lasts.
- Conditions
- Cerebrovascular Accident
- Keywords
- Anesthesia, Magnetic Stimulation, Motor, Neuroplasticity, Practice, Rehabilitation, Stroke
- 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 posted18 Oct 2000 (estimated)
- Study startOct 2000
- Study completionMar 2006
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
- 12 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
- NCT00006414
- Sponsor's protocol ID
- 010002
- Other IDs
- 01-N-0002
- Status last verified
- Mar 2006
- First submitted
- 17 Oct 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Schlaug G, Knorr U, Seitz R. Inter-subject variability of cerebral activations in acquiring a motor skill: a study with positron emission tomography. Exp Brain Res. 1994;98(3):523-34. doi: 10.1007/BF00233989.
PubMed 8056072Nudo RJ, Milliken GW, Jenkins WM, Merzenich MM. Use-dependent alterations of movement representations in primary motor cortex of adult squirrel monkeys. J Neurosci. 1996 Jan 15;16(2):785-807. doi: 10.1523/JNEUROSCI.16-02-00785.1996.
PubMed 8551360Matchar DB, McCrory DC, Barnett HJ, Feussner JR. Medical treatment for stroke prevention. Ann Intern Med. 1994 Jul 1;121(1):41-53. doi: 10.7326/0003-4819-121-1-199407010-00008.
PubMed 7880225
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
- Improvements of Hand Function in Chronic Stroke Related to Upper Arm Anesthesia
- ClinicalTrials.gov ID
- NCT00006414
- Acronym / sponsor ID
- 010002
- Conditions
- Cerebrovascular Accident
- Keywords
- Anesthesia, Magnetic Stimulation, Motor, Neuroplasticity, Practice, Rehabilitation, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- Mar 2006
- First posted
- 18 Oct 2000 (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 examine the effectiveness of an experimental treatment to improve hand function in patients who have had a stroke affecting one side of the body. One of the main problems of stroke patients is difficulty using the affected hand. Most treatments focus on acute (early) intervention, although special exercises may help some chronic patients. Previous studies have indicated that combining hand exercises with anesthesia (blocking motor and sensory function) of the upper arm may improve hand movement in stroke patients, even in the chronic state. This study will examine whether the exercise plus anesthesia treatment is more beneficial for these patients over the long-term than exercise alone.
Patients 18 years or older who are at least 12 months post stroke, which has affected only one side of the body, may be eligible for this study. Candidates will have a medical history and physical and neurological examinations.
Participants will be randomly divided into two groups: one will practice hand exercises without upper arm anesthesia and the other will exercise with anesthesia. All patients will perform two consecutive sessions of 30-minute pinch practice-forceful pinching of the thumb and index finger. Patients in the anesthesia group will have the anesthetic injected in the lower neck. Enough anesthetic will be administered to block motor and sensory function in the shoulder and upper arm, while maintaining as much function as possible in the forearm and hand.
All patients will also have transcranial magnetic stimulation (TMS) testing. For this procedure, a very brief electrical current is passed through an insulated wire coil placed on the head, producing a magnetic pulse. The pulse travels through the scalp and skull and causes small electrical currents in the outer part of the brain. During the study, the patient will be asked to make movements, do simple tasks, or tense muscles, while the electrical activity of the muscles is recorded.
Patients will have four sessions at 3-week intervals and three follow-up sessions at 3 weeks, 9 weeks and 24 weeks after the testing. Follow-up evaluations will include pinch power testing, TMS, sensory function test and hand function measurement.
Detailed description
The purpose of this protocol is to enhance our understanding of the effect of regional anesthesia of the proximal arm paired with practice on motor recovery after stroke. We plan to determine; 1) if regional anesthesia of the proximal arm (above the elbow level) paired with practice in chronic disabled stroke patients enhances an improvement of the hand motor function in addition to motor power; 2) if further enhancement of motor improvement can be achieved by repetitive trials of this intervention; and 3) how long this effect lasts.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Twelve hemispheric patients (right or left) with residual arm function who had a single monohemispheric stroke (documented by CT or MRI) at least 12 months before, without severe proprioceptive deficits, independent of previous physical therapy will be included.
- They should all be able to perform the training task.
Key exclusion criteria (12 listed)
- Excluded from the study will be: patients with more than one stroke;
- patients with large cortical, cerebellar or brainstem lesions;
- Patients unable to extend metacarpophalangeal (MP) joints at least 10-20 degrees;
- Patients unable to extend the wrist at least 20 degrees;
- Patients with substantially recovered motor function;
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 8056072Schlaug G, Knorr U, Seitz R. Inter-subject variability of cerebral activations in acquiring a motor skill: a study with positron emission tomography. Exp Brain Res. 1994;98(3):523-34. doi: 10.1007/BF00233989.
- Background: PubMed 8551360Nudo RJ, Milliken GW, Jenkins WM, Merzenich MM. Use-dependent alterations of movement representations in primary motor cortex of adult squirrel monkeys. J Neurosci. 1996 Jan 15;16(2):785-807. doi: 10.1523/JNEUROSCI.16-02-00785.1996.
- Background: PubMed 7880225Matchar DB, McCrory DC, Barnett HJ, Feussner JR. Medical treatment for stroke prevention. Ann Intern Med. 1994 Jul 1;121(1):41-53. doi: 10.7326/0003-4819-121-1-199407010-00008.
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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 2 inclusion and 12 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 NCT00006414, 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.