Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation

Cerebrovascular Accident Clinical Trial

Official title:

Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351947
• Other study ID #: B6636W
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 2018

Study information

• Verified date: April 2022
• Source: Louis Stokes VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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).

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland Department of Veterans Affairs Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months
Primary	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.	Day 1 and following 3 months of intervention