Cerebrovascular AccidentNCT00001553
Motor Changes Associated With Recovery From Stroke After Therapy
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Researchers have been interested in the changes associated with motor function in humans after suffering a stroke. Presently, the mechanism by which a person recovers motor function following a stroke is poorly understood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to Mar 2001
- 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
Patients with stroke more than 1 year before testing.
Patients with right cortico-subcortical strokes will be included.
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: Functional Changes Associated With Recovery of Motor Function in Chronic Ischemic Subcortical Stroke After a Therapeutic Intervention
Researchers have been interested in the changes associated with motor function in humans after suffering a stroke. Presently, the mechanism by which a person recovers motor function following a stroke is poorly understood. There is little information available about the areas of the brain involved in the recovery of limb function.
Recently, a new set of techniques have been developed that may be useful for reducing the physical impairment often associated with strokes.
Read more
The best way to identify the areas of the brain associated with regaining function is to test patients before, during, and after function is regained.
This study will compare two therapies and determine which is better at improving recovery of motor function. The first technique involves immobilizing the functional limb and actively training the affected dysfunctional limb. The second technique involves no immobilization, and passive movement of the affected limb.
Results from this study will indicate which of the two therapies is better at improving motor function. Additional diagnostic tests will help to identify changes in brain function associated with recovered use of affected limbs.
Read the detailed description
We have been interested in the study of plastic changes associated with recovery of motor function in humans after a variety of lesions in the central (spinal cord injury) and peripheral nervous system (amputation, reversible deafferentation) and motor learning. At present, mechanisms underlying recovery of motor function after stroke are poorly understood. Little and inconsistent information is available about the specific brain regions newly recruited in patients with chronic ischemic subcortical stroke after reacquisition of use of the affected limb.
Recently, a new set of techniques proposed to be useful for reducing the chronic incapacitating motor impairment often associated with stroke has been developed. In essence, it consists of prolonged restraint of the unaffected upper extremity and practice in using the affected arm. These techniques increased significantly the use of the affected arm in daily activities in the two trials reported. The beneficial effect, once produced, appeared to last for years after the intervention.
The best way to identify the brain regions associated with reacquisition of motor function after stroke is to test patients before, during and after reacquisition is accomplished. In this case, we propose that patients be tested before, during and after one of two specific interventions: one involving immobilization of healthy arm plus active training of affected arm (test procedure) and the other involving no immobilization, and passive manipulations of the affected arm. Results from this study will indicate which of the two therapies is better at improving recovery of motor function. Comparison of neurophysiological and imaging studies performed before, during and after the interventions will allow identification of plastic changes in brain function associated specifically with the recovery of use of the affected hand in patients with chronic ischemic subcortical stroke.
Methodologically, a multimodality approach will be used. Magnetic stimulation will allow detailed analysis of maps of representation areas in the primary motor cortex and motor thresholds and evaluation of central motor conduction. EEG and movement-related cortical potentials will provide information about coherence and timing of activation of different brain regions. PET scan will identify regions activated in association with performance of motor tasks. Registration of this information onto MRI will allow precise identification of brain regions associated with reacquisition of motor skills on the affected side after stroke.
We hypothesize that use of the affected arm associated with decreased use of the unaffected arm are useful triggers of plasticity and reacquisition of motor function after stroke. We expect to identify cortical and subcortical regions newly activated in each patient after reacquisition of use of the affected arm, understand the coherence and timing of activation of new brain regions recruited and quantify plastic changes in motor representation areas targeting arm muscles in the affected and unaffected arm.
- Conditions
- Cerebrovascular Accident
- Keywords
- Plasticity, Recovery, Stroke, Use, Cortico-subcortical 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 posted10 Dec 2002 (estimated)
- Study startMay 1996
- Study completionMar 2001
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
- 20 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
- NCT00001553
- Sponsor's protocol ID
- 960090
- Other IDs
- 96-N-0090
- Status last verified
- Apr 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Aram DM, Rose DF, Rekate HL, Whitaker HA. Acquired capsular/striatal aphasia in childhood. Arch Neurol. 1983 Oct;40(10):614-7. doi: 10.1001/archneur.1983.04050090050007.
PubMed 6193770Bowers D, Heilman KM, Satz P, Altman A. Simultaneous performance on verbal, nonverbal and motor tasks by right-handed adults. Cortex. 1978 Dec;14(4):540-56. doi: 10.1016/s0010-9452(78)80029-x.
PubMed 738063Brown JW, Leader BJ, Blum CS. Hemiplegic writing in severe aphasia. Brain Lang. 1983 Jul;19(2):204-15. doi: 10.1016/0093-934x(83)90065-2.
PubMed 6192867
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
- Functional Changes Associated With Recovery of Motor Function in Chronic Ischemic Subcortical Stroke After a Therapeutic Intervention
- ClinicalTrials.gov ID
- NCT00001553
- Acronym / sponsor ID
- 960090
- Conditions
- Cerebrovascular Accident
- Keywords
- Plasticity, Recovery, Stroke, Use, Cortico-subcortical Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 1996
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (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.
Researchers have been interested in the changes associated with motor function in humans after suffering a stroke. Presently, the mechanism by which a person recovers motor function following a stroke is poorly understood. There is little information available about the areas of the brain involved in the recovery of limb function.
Recently, a new set of techniques have been developed that may be useful for reducing the physical impairment often associated with strokes.
The best way to identify the areas of the brain associated with regaining function is to test patients before, during, and after function is regained.
This study will compare two therapies and determine which is better at improving recovery of motor function. The first technique involves immobilizing the functional limb and actively training the affected dysfunctional limb. The second technique involves no immobilization, and passive movement of the affected limb.
Results from this study will indicate which of the two therapies is better at improving motor function. Additional diagnostic tests will help to identify changes in brain function associated with recovered use of affected limbs.
Detailed description
We have been interested in the study of plastic changes associated with recovery of motor function in humans after a variety of lesions in the central (spinal cord injury) and peripheral nervous system (amputation, reversible deafferentation) and motor learning. At present, mechanisms underlying recovery of motor function after stroke are poorly understood. Little and inconsistent information is available about the specific brain regions newly recruited in patients with chronic ischemic subcortical stroke after reacquisition of use of the affected limb.
Recently, a new set of techniques proposed to be useful for reducing the chronic incapacitating motor impairment often associated with stroke has been developed. In essence, it consists of prolonged restraint of the unaffected upper extremity and practice in using the affected arm. These techniques increased significantly the use of the affected arm in daily activities in the two trials reported. The beneficial effect, once produced, appeared to last for years after the intervention.
The best way to identify the brain regions associated with reacquisition of motor function after stroke is to test patients before, during and after reacquisition is accomplished. In this case, we propose that patients be tested before, during and after one of two specific interventions: one involving immobilization of healthy arm plus active training of affected arm (test procedure) and the other involving no immobilization, and passive manipulations of the affected arm. Results from this study will indicate which of the two therapies is better at improving recovery of motor function. Comparison of neurophysiological and imaging studies performed before, during and after the interventions will allow identification of plastic changes in brain function associated specifically with the recovery of use of the affected hand in patients with chronic ischemic subcortical stroke.
Methodologically, a multimodality approach will be used. Magnetic stimulation will allow detailed analysis of maps of representation areas in the primary motor cortex and motor thresholds and evaluation of central motor conduction. EEG and movement-related cortical potentials will provide information about coherence and timing of activation of different brain regions. PET scan will identify regions activated in association with performance of motor tasks. Registration of this information onto MRI will allow precise identification of brain regions associated with reacquisition of motor skills on the affected side after stroke.
We hypothesize that use of the affected arm associated with decreased use of the unaffected arm are useful triggers of plasticity and reacquisition of motor function after stroke. We expect to identify cortical and subcortical regions newly activated in each patient after reacquisition of use of the affected arm, understand the coherence and timing of activation of new brain regions recruited and quantify plastic changes in motor representation areas targeting arm muscles in the affected and unaffected arm.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 6193770Aram DM, Rose DF, Rekate HL, Whitaker HA. Acquired capsular/striatal aphasia in childhood. Arch Neurol. 1983 Oct;40(10):614-7. doi: 10.1001/archneur.1983.04050090050007.
- Background: PubMed 738063Bowers D, Heilman KM, Satz P, Altman A. Simultaneous performance on verbal, nonverbal and motor tasks by right-handed adults. Cortex. 1978 Dec;14(4):540-56. doi: 10.1016/s0010-9452(78)80029-x.
- Background: PubMed 6192867Brown JW, Leader BJ, Blum CS. Hemiplegic writing in severe aphasia. Brain Lang. 1983 Jul;19(2):204-15. doi: 10.1016/0093-934x(83)90065-2.
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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.
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 NCT00001553, 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.