Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
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|ClinicalTrials.gov Identifier: NCT02351947|
Recruitment Status : Unknown
Verified March 2017 by Svetlana Pundik, M.D., Louis Stokes VA Medical Center.
Recruitment status was: Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Other: upper limb rehabilitation for chronic stroke||Not Applicable|
A third of American Veterans is left with moderate to severe motor deficits after stroke. Intensive rehabilitation can resolve some of these deficits. Motor function restoration is associated with and dependent on reorganization of neuronal networks (i.e. plasticity). However, our understanding of human brain plasticity during functional recovery is incomplete. Furthermore, it is unknown what patterns of structural brain changes are associated with greater gains in motor function as a result of motor learning therapy. The main objective of the study is to characterize the reorganization of brain structure and function that is associated with greater gains in motor function following restorative rehabilitation for chronic survivors. This will further our understanding of recovery after brain injury and subsequently assist in more accurately directing rehabilitation therapies to produce the best possible outcomes.
The two hypotheses are: I. There is reorganization of both movement control brain regions and pathways between regions that is associated with functional motor recovery in response to intensive motor learning after stroke; and II. For stroke victims with upper extremity deficits, motor recovery is associated with changes in the sequential timing of activity across cortical regions.
Design and Methods. A cohort of chronic stroke survivors with upper extremity deficits will be treated by our intensive multimodal 12-week motor learning program. Brain imaging (functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI)) and neurophysiological (Electroencephalogram (EEG)) studies as well as functional motor tests (Arm Motor Activity test and Fugl-Meyer Coordination test) will be obtained before and after the treatment. Age-matched control subjects will be evaluated as well. DTI/fMRI and EEG/fMRI combination techniques will be used to determine changes in brain structure and function as a result of the treatments. A regression analysis will determine which brain structure parameters can predictor greater motor function gains.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: persons with chronic stroke
upper limb rehabilitation for chronic stroke
Other: upper limb rehabilitation for chronic stroke
subjects in this group will receive upper limb motor learning rehabilitation and undergo fMRI/EEG testing as well as testing of motor function (AMAT and FM).
No Intervention: Healthy, age matched control group
Healthy aged match control group undergoing MRI/EEG testing
- functional MRI during movement of the shoulder and elbow [ Time Frame: up to 3 months ]MRI allows for observation of the internal structures of the body using a magnetic field and radiowaves. We will measure activation voxel count in response to training.
- Electroencephalography (EEG) during movement of the shoulder and elbow [ Time Frame: Day 1 and following 3 months of intervention ]EEG is used to record electrical signals released by the brain. We will assess changes in the movement related cortical potentional (MRCP, measured in microvolts) in response to training.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351947
|United States, Ohio|
|Louis Stokes Cleveland Department of Veterans Affairs Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Svetlana Pundik, M.D.||Louis Stokes VA Medical Center|