Observational Learning in Stroke Patients
| Tracking Information | |
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| First Received Date ICMJE | May 27, 2004 |
| Last Updated Date | June 17, 2008 |
| Start Date ICMJE | May 2004 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00083642 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Observational Learning in Stroke Patients |
| Official Title ICMJE | Neural Correlates of Observational Motor Learning in Chronic Stroke Patients |
| Brief 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. 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:
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| 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 Type ICMJE | Observational |
| Study Design ICMJE | Not Provided |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE | Stroke |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Byrne RW, Russon AE. Learning by imitation: a hierarchical approach. Behav Brain Sci. 1998 Oct;21(5):667-84; discussion 684-721. Review. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 60 |
| Completion Date | June 2008 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE |
We will include PATIENTS:
As a control group, we will include NORMAL VOLUNTEERS,
EXCLUSION CRITERIA:
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| Gender | Both |
| Ages | 18 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00083642 |
| Other Study ID Numbers ICMJE | 040203, 04-N-0203 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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