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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
Sponsor:
Information provided by (Responsible Party):
Svetlana Pundik, M.D., Louis Stokes VA Medical Center

Brief Summary:
The purpose of this research study is to improve methods for evaluation of brain changes during motor learning for patients with stroke, who have difficulty performing daily tasks with their arm and hand. The methods for evaluation of brain changes will consist of the combination of magnetic resonance imaging (MRI) and electroencephalography (EEG).

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Other: upper limb rehabilitation for chronic stroke Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for chronic stroke patients:

  1. Medically stable and at least 6 months post ischemic stroke.
  2. Inability to use upper limb for functional tasks
  3. Sufficient endurance to participate in rehabilitation
  4. Cognition sufficiently intact to give valid informed consent to participate
  5. Ability to follow two stage commands
  6. Trace or better contraction of the following muscles: finger flexors, wrist flexors and extensors, shoulder flexors or abductors, shoulder horizontal abductors, scapular retractors
  7. Muscle tone of fingers, wrist and elbow flexors ≤3 (Ashworth scale)
  8. Age > 21

Exclusion Criteria

  1. Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy
  2. Active psychiatric diagnosis or psychological condition
  3. Lower motor neuron damage or radiculopathy
  4. Hand grasp and release sufficient to grasp 4 oz. can, lift 12 inches, replace it in original position and release grasp within 1-2 seconds of the time of the unaffected extremity
  5. Absent position sense at elbow or wrist
  6. More than one ischemic strokes or stroke affecting both sides
  7. Metal implants, pacemaker, claustrophobia, or inability to operate the MRI patient call button

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Louis Stokes VA Medical Center
Investigators
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Principal Investigator: Svetlana Pundik, M.D. Louis Stokes VA Medical Center

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Responsible Party: Svetlana Pundik, M.D., Director, Brain Plasticity and Neurorecovery Laboratory, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT02351947     History of Changes
Other Study ID Numbers: B6636W
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Keywords provided by Svetlana Pundik, M.D., Louis Stokes VA Medical Center:
stroke
Cerebrovascular accident
rehabilitation
motor learning
fMRI
plasticity

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases