Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatment upper limb rehabilitation for chronic stroke
Sponsor Louis Stokes VA Medical Center
Start date January 2010
End date January 2017
Trial size 24 participants
Trial identifier NCT02351947, B6636W

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
upper limb rehabilitation for chronic stroke
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 aged match control group undergoing MRI/EEG testing

Primary Outcomes

Measure
functional MRI during movement of the shoulder and elbow
time frame: up to 3 months
Electroencephalography (EEG) during movement of the shoulder and elbow
time frame: Day 1 and following 3 months of intervention

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Structural and Functional Brain Changes in Response to Post-Stroke Rehabilitation
Principal investigator Svetlana Pundik, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Louis Stokes VA Medical Center.