Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
upper limb rehabilitation for chronic stroke
Sponsored by

About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring stroke, Cerebrovascular accident, rehabilitation, motor learning, fMRI, plasticity
Eligibility Criteria
Inclusion Criteria for chronic stroke patients:
- Medically stable and at least 6 months post ischemic stroke.
- Inability to use upper limb for functional tasks
- Sufficient endurance to participate in rehabilitation
- Cognition sufficiently intact to give valid informed consent to participate
- Ability to follow two stage commands
- Trace or better contraction of the following muscles: finger flexors, wrist flexors and extensors, shoulder flexors or abductors, shoulder horizontal abductors, scapular retractors
- Muscle tone of fingers, wrist and elbow flexors ≤3 (Ashworth scale)
- Age > 21
Exclusion Criteria
- Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy
- Active psychiatric diagnosis or psychological condition
- Lower motor neuron damage or radiculopathy
- 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
- Absent position sense at elbow or wrist
- More than one ischemic strokes or stroke affecting both sides
- Metal implants, pacemaker, claustrophobia, or inability to operate the MRI patient call button
Sites / Locations
- Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
persons with chronic stroke
Healthy, age matched control group
Arm Description
upper limb rehabilitation for chronic stroke
Healthy aged match control group undergoing MRI/EEG testing
Outcomes
Primary Outcome Measures
functional MRI during movement of the shoulder and elbow
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02351947
First Posted
December 16, 2014
Last Updated
April 4, 2022
Sponsor
Louis Stokes VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02351947
Brief Title
Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
Official Title
Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louis Stokes VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
stroke, Cerebrovascular accident, rehabilitation, motor learning, fMRI, plasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
persons with chronic stroke
Arm Type
Experimental
Arm Description
upper limb rehabilitation for chronic stroke
Arm Title
Healthy, age matched control group
Arm Type
No Intervention
Arm Description
Healthy aged match control group undergoing MRI/EEG testing
Intervention Type
Other
Intervention Name(s)
upper limb rehabilitation for chronic stroke
Intervention Description
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).
Primary Outcome Measure Information:
Title
functional MRI during movement of the shoulder and elbow
Description
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.
Time Frame
up to 3 months
Title
Electroencephalography (EEG) during movement of the shoulder and elbow
Description
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.
Time Frame
Day 1 and following 3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for chronic stroke patients:
Medically stable and at least 6 months post ischemic stroke.
Inability to use upper limb for functional tasks
Sufficient endurance to participate in rehabilitation
Cognition sufficiently intact to give valid informed consent to participate
Ability to follow two stage commands
Trace or better contraction of the following muscles: finger flexors, wrist flexors and extensors, shoulder flexors or abductors, shoulder horizontal abductors, scapular retractors
Muscle tone of fingers, wrist and elbow flexors ≤3 (Ashworth scale)
Age > 21
Exclusion Criteria
Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy
Active psychiatric diagnosis or psychological condition
Lower motor neuron damage or radiculopathy
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
Absent position sense at elbow or wrist
More than one ischemic strokes or stroke affecting both sides
Metal implants, pacemaker, claustrophobia, or inability to operate the MRI patient call button
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik, M.D.
Organizational Affiliation
Louis Stokes VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
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Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
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