StrokeNCT00083642
Observational Learning in Stroke Patients
An observational study of Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine how people who have had a stroke learn to perform a movement by observation, as compared with people who have not had a stroke. Normally, a person learns a new hand movement automatically by observing the movement performed by others. Improvement with practice also relies on visual feedback. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2004to 13 Jun 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include PATIENTS:
- Who are aged 18 to 75,
- With a single thromboembolic non-hemorrhagic hemispheric lesions,
- With at least a 3 months period since the stroke,
- Who initially had a severe motor paresis (below MRC grade 2),
- Who subsequently recovered to the point that they can perform the motor tasks of this study,
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- With no history of other neurological and psychiatric illness,
- Who are right-handed (before the stroke history).
- As a control group, we will include NORMAL VOLUNTEERS,
- Who are age- and gender matched to stroke PATIENTS,
- Who can perform the motor tasks of this study,
- With no history of other neurological and psychiatric illness,
- Who are right-handed.
Who cannot join
- PATIENTS with more than one stroke in the medial cerebral artery territory.
- PATIENTS with bilateral motor impairment.
- PATIENTS with cerebellar or brainstem lesions.
- PATIENTS and NORMAL VOLUNTEERS unable to perform the task.
- PATIENTS and NORMAL VOLUNTEERS with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
- PATIENTS and NORMAL VOLUNTEERS with 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).
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- PATIENTS and NORMAL VOLUNTEERS with increased intracranial pressure (as evaluated by clinical examination).
- PATIENTS and NORMAL VOLUNTEERS with unstable cardiac arrhythmia.
- PATIENTS and NORMAL VOLUNTEERS with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
- PATIENTS and NORMAL VOLUNTEERS with more than moderate to severe microangiopathy (as assessed by multiple peri-ventricular T2 hyperintensity on the pre-experimental anatomical MRI), polyneuropathy (as assessed by clinical examination), diabetes mellitus (medical record), or ischemic peripheral disease (as assessed by clinical examination).
- PATIENTS and NORMAL VOLUNTEERS who are or who have been good skilled piano or string instruments players.
- PATIENTS and NORMAL VOLUNTEERS who is on medication with the potential to influence nervous system function, who has a history of surgery with metallic implants or a known history of metallic particles in the eye, a cardiac pacemaker, intracardiac lines, neural stimulators, cochlear implants.
- PATIENTS and NORMAL VOLUNTEERS who are pregnant.
- PATIENTS and NORMAL VOLUNTEERS with significant visual loss/deficits.
- PATIENTS and NORMAL VOLUNTEERS with MRI contraindications.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Neural Correlates of Observational Motor Learning in Chronic Stroke Patients
This study will determine how people who have had a stroke learn to perform a movement by observation, as compared with people who have not had a stroke. Normally, a person learns a new hand movement automatically by observing the movement performed by others. Improvement with practice also relies on visual feedback. This "observational training" - i.e., the repeated observation of a movement - is sufficient for normal individuals to learn a movement. This study will examine brain activity related to motor learning in stroke patients and in healthy control subjects to see whether stroke patients process visual-motor information the same way normal subjects do.
Normal volunteers and stroke patients between 18 and 75 years of age may be eligible for this study. Patients must have had paralysis on one side of the body due to a stroke that occurred at least 3 months before entering the study. Candidates who have not had a recent health screening will have a clinical and neurological examination.
Read more
Participants undergo the following procedures:
- Brain magnetic resonance imaging (MRI), if one has not been done recently. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that can slide in and out of the cylindrical scanner and wears earplugs to muffle loud noises caused by switching of magnetic fields. Scanning time varies from 20 minutes to 3 hours, with most sessions lasting 45 to 90 minutes.
- Task training. The subject practices the task to be performed during functional MRI (see below). The subject makes finger tapping movements, then watches finger movements on a video screen for several minutes, during which time the movie stops from time to time without warning. When the movie stops, the subject must reproduce the last finger movement that appeared on the screen. During this session, the electrical signals of the subject's forearm muscles are recorded at the skin surface. This session lasts up to 3 hours.
- Functional MRI. The subject undergoes MRI scanning while performing the same tasks done in the training session. This session lasts about 3 hours.
Read the detailed description
In normal subjects, the learning of new hand movements initially relies on the automatic ability to elaborate a motor plan from the simple observation of movements performed by others. The improvement of motor performance during practice also relies on a correct visuomotor processing of visual feedback and it has been demonstrated that the repeated observation of a gesture, named observational training is sufficient to induce motor learning. However, it is not known if stroke patients process visuomotor information in the same manner as normal subjects.
Objectives:
The purpose of this protocol is to determine the pattern of brain activations related to motor learning induced by observational training in stroke patients as compared to normal volunteers. We hypothesize that observational motor learning in stroke patients will rely on an increased activity in premotor cortex as compared to normal volunteers.
Study population:
This protocol will include chronic stroke patients with subcortical lesions and good motor recovery from an initial upper-limb paresis, and a control population of age and gender matched normal volunteers.
Design:
We will conduct a functional MRI (fMRI) experiment assessing observational training of finger sequences. Three conditions of finger sequences will be compared: 1) a sequence visually trained during the fMRI session, 2) a non-trained sequence (control 1), and 3) a sequence visually trained before the fMRI session (control 2). The fMRI session will be split into 3 separate runs. The first run will assess brain activity related to the motor performance of the 3 finger sequences. The second run will explore the brain activity during observational training of the sequence. The third run will re-assess the brain activity related to the motor performance of the 3 finger sequences.
Outcome measures:
The endpoint measure of the experiment will be an increase in the number of activated voxels in premotor cortex during the motor learning induced by observational training in the stroke patients as compared to normal volunteers.
- Conditions
- Stroke
- Keywords
- Brain Plasticity, Functional MRI, Finger Movement, Rehabilitation, Improvement, Stroke, Motor Recovery, Observation, fMRI, Healthy Volunteer, HV
- 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 posted27 May 2004 (estimated)
- Study start25 May 2004
- Study completion13 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 60 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
- NCT00083642
- Sponsor's protocol ID
- 040203
- Other IDs
- 04-N-0203
- Status last verified
- 13 Jun 2008
- First submitted
- 27 May 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Byrne RW, Russon AE. Learning by imitation: a hierarchical approach. Behav Brain Sci. 1998 Oct;21(5):667-84; discussion 684-721. doi: 10.1017/s0140525x98001745.
PubMed 10097023
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Observational Motor Learning in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT00083642
- Acronym / sponsor ID
- 040203
- Conditions
- Stroke
- Keywords
- Brain Plasticity, Functional MRI, Finger Movement, Rehabilitation, Improvement, Stroke, Motor Recovery, Observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 25 May 2004
- Study completion
- 13 Jun 2008
- First posted
- 27 May 2004 (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 how people who have had a stroke learn to perform a movement by observation, as compared with people who have not had a stroke. Normally, a person learns a new hand movement automatically by observing the movement performed by others. Improvement with practice also relies on visual feedback. This "observational training" - i.e., the repeated observation of a movement - is sufficient for normal individuals to learn a movement. This study will examine brain activity related to motor learning in stroke patients and in healthy control subjects to see whether stroke patients process visual-motor information the same way normal subjects do.
Normal volunteers and stroke patients between 18 and 75 years of age may be eligible for this study. Patients must have had paralysis on one side of the body due to a stroke that occurred at least 3 months before entering the study. Candidates who have not had a recent health screening will have a clinical and neurological examination.
Participants undergo the following procedures:
- Brain magnetic resonance imaging (MRI), if one has not been done recently. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that can slide in and out of the cylindrical scanner and wears earplugs to muffle loud noises caused by switching of magnetic fields. Scanning time varies from 20 minutes to 3 hours, with most sessions lasting 45 to 90 minutes.
- Task training. The subject practices the task to be performed during functional MRI (see below). The subject makes finger tapping movements, then watches finger movements on a video screen for several minutes, during which time the movie stops from time to time without warning. When the movie stops, the subject must reproduce the last finger movement that appeared on the screen. During this session, the electrical signals of the subject's forearm muscles are recorded at the skin surface. This session lasts up to 3 hours.
- Functional MRI. The subject undergoes MRI scanning while performing the same tasks done in the training session. This session lasts about 3 hours.
Detailed description
In normal subjects, the learning of new hand movements initially relies on the automatic ability to elaborate a motor plan from the simple observation of movements performed by others. The improvement of motor performance during practice also relies on a correct visuomotor processing of visual feedback and it has been demonstrated that the repeated observation of a gesture, named observational training is sufficient to induce motor learning. However, it is not known if stroke patients process visuomotor information in the same manner as normal subjects.
Objectives:
The purpose of this protocol is to determine the pattern of brain activations related to motor learning induced by observational training in stroke patients as compared to normal volunteers. We hypothesize that observational motor learning in stroke patients will rely on an increased activity in premotor cortex as compared to normal volunteers.
Study population:
This protocol will include chronic stroke patients with subcortical lesions and good motor recovery from an initial upper-limb paresis, and a control population of age and gender matched normal volunteers.
Design:
We will conduct a functional MRI (fMRI) experiment assessing observational training of finger sequences. Three conditions of finger sequences will be compared: 1) a sequence visually trained during the fMRI session, 2) a non-trained sequence (control 1), and 3) a sequence visually trained before the fMRI session (control 2). The fMRI session will be split into 3 separate runs. The first run will assess brain activity related to the motor performance of the 3 finger sequences. The second run will explore the brain activity during observational training of the sequence. The third run will re-assess the brain activity related to the motor performance of the 3 finger sequences.
Outcome measures:
The endpoint measure of the experiment will be an increase in the number of activated voxels in premotor cortex during the motor learning induced by observational training in the stroke patients as compared to normal volunteers.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Who are aged 18 to 75,
- With a single thromboembolic non-hemorrhagic hemispheric lesions,
- With at least a 3 months period since the stroke,
- Who initially had a severe motor paresis (below MRC grade 2),
- Who subsequently recovered to the point that they can perform the motor tasks of this study,
Key exclusion criteria (15 listed)
- PATIENTS with more than one stroke in the medial cerebral artery territory.
- PATIENTS with bilateral motor impairment.
- PATIENTS with cerebellar or brainstem lesions.
- PATIENTS and NORMAL VOLUNTEERS unable to perform the task.
- PATIENTS and NORMAL VOLUNTEERS with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 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 2 Jul 2017.
- Background: PubMed 10097023Byrne RW, Russon AE. Learning by imitation: a hierarchical approach. Behav Brain Sci. 1998 Oct;21(5):667-84; discussion 684-721. doi: 10.1017/s0140525x98001745.
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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, 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 13 inclusion and 15 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 2 Jul 2017. 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 NCT00083642, which also lists 1 linked publication.
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 2 Jul 2017.