Viewing Study NCT00083642



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00083642
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2004-05-27

Brief Title: Observational Learning in Stroke Patients
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Neural Correlates of Observational Motor Learning in Chronic Stroke Patients
Status: COMPLETED
Status Verified Date: 2008-06-13
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 - ie 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 subjects 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
04-N-0203 None None None