Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

Phase 2

Completed

Brief Summary: This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Mean Change in FM-UE From Baseline	Day 15	The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted.

Secondary Outcome Measures

Name	Time	Method
Mean Change in SIS Hand Subscale From Baseline	Day 15	The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best).
Mean Change in WMFT Time Score From Baseline	Day 15	The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better.

Locations (14): University of Alabama at Birmingham Hospital
🇺🇸
Birmingham, Alabama, United States
Keck Hospital of USC
🇺🇸
Los Angeles, California, United States
Emory Rehabilitation Hospital
🇺🇸
Atlanta, Georgia, United States
Cardinal Hill Rehabilitation Hospital
🇺🇸
Lexington, Kentucky, United States
Burke Rehabilitation Center
🇺🇸
White Plains, New York, United States
Duke University Hospital
🇺🇸
Durham, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center Presbyterian Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina University Hospital
🇺🇸
Charleston, South Carolina, United States
Memorial Hermann Texas Medical Center
🇺🇸
Houston, Texas, United States
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University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States