StrokeNCT00021710
Motor Learning in Stroke Patients and Healthy Volunteers
An observational study of Stroke and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will try to elucidate learning processes associated with motor training in the weak arm of stroke patients compared with healthy controls. Results from previous clinical trials indicate that training may enhance motor function in healthy volunteers, and perhaps also in stroke patients, even more than 1 year… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jun 2005
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 18 years to 100 years
- Normal physical and neurological examinations
- Age: 18 years to 100 years
- Single ischemic or hemorrhagic hemispheric stroke at least one year before enrollment in study, confirmed by neuroimaging studies (computerized tomography or magnetic resonance imaging).
- Ability to perform the Jebsen-Taylor test.
Who cannot join
- Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures
- More than one stroke.
- Other brain lesions (i.e., traumatic brain injury, brain tumor) or neurological problems (i.e., multiple sclerosis, dementia, Parkinson's disease)
- Depression or poor motivational capacity
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less).
- Inability to understand instructions for the Jebsen-Taylor test.
- Uncontrolled medical problems including 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, uncontrolled epilepsy
- Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures
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: Motor Learning: Behavioral and Physiologic Studies in Normal Volunteers and Stroke Patients
This study will try to elucidate learning processes associated with motor training in the weak arm of stroke patients compared with healthy controls. Results from previous clinical trials indicate that training may enhance motor function in healthy volunteers, and perhaps also in stroke patients, even more than 1 year after the stroke. Normal, healthy volunteers and stroke patients 18 years of age and older may be eligible for this study.
Study subjects will have a physical examination and participate in 6 additional clinic visits-training and testing sessions on study days 1, 2, 3, 4 and 5, and a final testing session on day 12. During these sessions, they will perform a series of motor tasks, including writing, picking up objects, turning cards, stacking checkers and moving cans, which will be timed and videotaped. Each session will be divided into blocks of 10 trials for each task, separated by 2-minute rest periods.
Read more
Before and after training on days 1, 2, 5 and 12, subjects will have transcranial magnetic stimulation (TMS) to determine brain changes associated with learning a motor task. For this procedure, the patient is seated in a comfortable chair, and an insulated wire coil is placed on the scalp or skin. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. These pulses generate very small electrical currents in the brain cortex, briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face, or limb. During the stimulation, the subject may be asked to slightly tense certain muscles or perform other simple actions.
Electrical nerve stimulation and electromyography will be done to record muscle responses to stimulation. A nerve is stimulated by placing wires on the skin over the nerve and passing a brief electrical current between the wires. Electromyography involves taping metal electrodes to the skin over the muscle.
Before and after each session, subjects' muscle strength will be tested with a pinch gauge. They will also be asked to make a mark on a line drawn on paper, to rate their test performance and levels of attentiveness and fatigue.
Read the detailed description
The purpose of this protocol is to characterize dynamics of motor learning over a 5-day period in chronic stroke patients relative to healthy age-matched controls. Motor learning will be assessed by improvements in the Jebsen-Taylor test, a validated tool widely used in rehabilitation that measures upper extremity function. Additionally, we intend to evaluate changes in the excitability of the primary motor cortex associated with learning using transcranial magnetic stimulation.
- Keywords
- Stroke, Learning, Plasticity, Motor, Rehabilitation, Premotor, Normal Control, Healthy Volunteer, HV, Motor Learning
- 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 posted3 Aug 2001 (estimated)
- Study startJul 2001
- Study completionJun 2005
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 StrokeStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021710
- Sponsor's protocol ID
- 010220
- Other IDs
- 01-N-0220
- Status last verified
- Jun 2005
- First submitted
- 2 Aug 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Boyd LA, Winstein CJ. Implicit motor-sequence learning in humans following unilateral stroke: the impact of practice and explicit knowledge. Neurosci Lett. 2001 Jan 26;298(1):65-9. doi: 10.1016/s0304-3940(00)01734-1.
PubMed 11154837Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
PubMed 2927652Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.
PubMed 7650532
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
- Motor Learning: Behavioral and Physiologic Studies in Normal Volunteers and Stroke Patients
- ClinicalTrials.gov ID
- NCT00021710
- Acronym / sponsor ID
- 010220
- Keywords
- Stroke, Learning, Plasticity, Motor, Rehabilitation, Premotor, Normal Control, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jul 2001
- Study completion
- Jun 2005
- First posted
- 3 Aug 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 try to elucidate learning processes associated with motor training in the weak arm of stroke patients compared with healthy controls. Results from previous clinical trials indicate that training may enhance motor function in healthy volunteers, and perhaps also in stroke patients, even more than 1 year after the stroke. Normal, healthy volunteers and stroke patients 18 years of age and older may be eligible for this study.
Study subjects will have a physical examination and participate in 6 additional clinic visits-training and testing sessions on study days 1, 2, 3, 4 and 5, and a final testing session on day 12. During these sessions, they will perform a series of motor tasks, including writing, picking up objects, turning cards, stacking checkers and moving cans, which will be timed and videotaped. Each session will be divided into blocks of 10 trials for each task, separated by 2-minute rest periods.
Before and after training on days 1, 2, 5 and 12, subjects will have transcranial magnetic stimulation (TMS) to determine brain changes associated with learning a motor task. For this procedure, the patient is seated in a comfortable chair, and an insulated wire coil is placed on the scalp or skin. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. These pulses generate very small electrical currents in the brain cortex, briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face, or limb. During the stimulation, the subject may be asked to slightly tense certain muscles or perform other simple actions.
Electrical nerve stimulation and electromyography will be done to record muscle responses to stimulation. A nerve is stimulated by placing wires on the skin over the nerve and passing a brief electrical current between the wires. Electromyography involves taping metal electrodes to the skin over the muscle.
Before and after each session, subjects' muscle strength will be tested with a pinch gauge. They will also be asked to make a mark on a line drawn on paper, to rate their test performance and levels of attentiveness and fatigue.
Detailed description
The purpose of this protocol is to characterize dynamics of motor learning over a 5-day period in chronic stroke patients relative to healthy age-matched controls. Motor learning will be assessed by improvements in the Jebsen-Taylor test, a validated tool widely used in rehabilitation that measures upper extremity function. Additionally, we intend to evaluate changes in the excitability of the primary motor cortex associated with learning using transcranial magnetic stimulation.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years to 100 years
- Normal physical and neurological examinations
- Age: 18 years to 100 years
- Single ischemic or hemorrhagic hemispheric stroke at least one year before enrollment in study, confirmed by neuroimaging studies (computerized tomography or magnetic resonance imaging).
- Ability to perform the Jebsen-Taylor test.
Key exclusion criteria (8 listed)
- Contraindications for transcranial magnetic stimulation: pacemaker, implanted medical pump, metal plate in skull, metal objects inside the eye or skull, history of seizures
- More than one stroke.
- Other brain lesions (i.e., traumatic brain injury, brain tumor) or neurological problems (i.e., multiple sclerosis, dementia, Parkinson's disease)
- Depression or poor motivational capacity
- Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 20 or less).
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 11154837Boyd LA, Winstein CJ. Implicit motor-sequence learning in humans following unilateral stroke: the impact of practice and explicit knowledge. Neurosci Lett. 2001 Jan 26;298(1):65-9. doi: 10.1016/s0304-3940(00)01734-1.
- Background: PubMed 2927652Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
- Background: PubMed 7650532Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.
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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 Stroke and Healthy, 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 5 inclusion and 8 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 NCT00021710, 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.