Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

Phase 2

Completed

• Conditions: Stroke, Ischemic; Motor Activity; Upper Extremity Paralysis
• Interventions: Device: High dose tDCS; Device: Low dose tDCS; Device: Sham; Behavioral: mCIMT

• Registration Number: NCT03826030
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-09-01
• Status Verified: 2024-07
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 mA + mCIMT	High dose tDCS	4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Sham tDCS + mCIMT	mCIMT	Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
2 mA tDCS + mCIMT	Low dose tDCS	2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Sham tDCS + mCIMT	Sham	Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
2 mA tDCS + mCIMT	mCIMT	2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
4 mA + mCIMT	mCIMT	4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Primary Outcome Measures

Name	Time	Method
Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale	Baseline through day 15 (after the intervention) and follow-up at day 45 and 105	The Fugl-Meyer Upper-Extremity (FM-UE) scale is a measure of motor impairment. FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater observes 30 voluntary UE motions and 14 voluntary lower extremity (LE) motions, 6 tendon tap responses, and provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). 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).

Secondary Outcome Measures

Name	Time	Method
Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)	Baseline through day 15 (after the intervention) and follow-up at day 45 and 105	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 consists of approximately 17 functional, strength and movement quality tasks. Each task is rated on a 6 point scale. Lower scores on the 6 point scale indicate lower functioning levels (1 = does not attempt with UE being tested, 2= UE being tested does not participate functionally, but an attempt is made to use the UE, 3= Does attempt but requires assistance of the UE not being tested, requires more than 2 attempts to complete, 4= Does attempt but may lack precision, fine coordination or fluidity, 5= Does attempt, movement similar to non-affected side but slightly slower, and 6= Does attempt and movement appears to be normal).
Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale	Baseline through day 15 (after the intervention) and follow-up at day 45 and 105	The SIS hand subscale assesses how having a stroke impacts a patient's life. The 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)

Trial Locations

Locations (14)

Burke Rehabilitation Center; 🇺🇸 White Plains, New York, United States

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

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

MedStar National Rehabilitation Hospital; 🇺🇸 Washington, District of Columbia, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Cleveland VA Medical Center; 🇺🇸 Cleveland, Ohio, United States

Moss Rehabilitation Research Institute; 🇺🇸 Elkins Park, Pennsylvania, United States