TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery A phase II sTudy (TRANSPORT 2)
Trial Summary: TRANSPORT 2 is a phase II multi-center transcranial direct current stimulation (tDCS) dosing selection study based on the preliminary efficacy, safety, tolerability and feasibility.
Primary Objective: To determine whether there is an overall treatment effect among 3 dosing groups (sham+mCIMT, 2 mA+mCIMT, and 4 mA+mCIMT) on day 15 (±2 days) after the start of the intervention in the Fugl-Meyer Upper-Extremity (FM-UE) scale, a measure of motor impairment. Additional outcome measures include the Wolf-Motor-Function-Test, a measure of functional motor activity, and the Stroke-Impact-Scale, a measure of quality of life. Sustained benefit will be assessed at day 45 (± 5 days) and day 105 (± 10 days).
Secondary Objectives: To confirm that the proposed intervention is safe (no significant differences in rate of adverse events), tolerable (no significant differences in discomfort as measured by Visual-Analog-Scale), and feasible to administer in a multi-site trial (>80% of subjects complete the treatment protocol and no unexplained/unresolved variability by site).
Exploratory Objectives: To examine whether wCST-LL (structural assessment of integrity of descending motor tract) or MEPs (functional assessment of integrity of descending motor tract) or combination of both are correlated with changes in FM-UE scale, and evaluate the utility of these measures as biomarkers for patient selection criteria in the future confirmatory Phase III study. We also aim to examine whether structural and functional changes within descending motor tracts and functional changes within cortical and subcortical motor network correlate with changes in motor impairment and functional motor activity.
Primary Endpoint: Fugl-Meyer Upper-Extremity (FM-UE) scale a measure of motor impairment;
Secondary Endpoints: Wolf Motor Function Test time score, a measure of functional motor activity; Stroke-Impact-Scale hand subscale as an assessment of patient-centered quality of life.
The study population is subjects who are 18-80 years of age of any gender or ethnicity, who had first-ever unihemispheric ischemic stroke in past 30-180 days resulting in unilateral limb weakness with FM-UE ≤ 54 (out of 66) that is stable across two baseline visits at the time of randomization and an mRS ≤ 2 pre-stroke. We are planning to enroll 129 subjects across three arms.
Subject recruitment will occur at up to 12 enrolling sites in the USA.
There are 3 intervention arms: sham, 2 mA, and 4 mA tDCS combined with modified Constrained-Induced Movement Therapy (mCIMT). The tDCS session is 30 minutes, and mCIMT is 60 minutes per session, 10 intervention sessions are completed over a 2-week (14 days) period.
The study duration is 48 months. Subjects will be in the trial for approximately 4 months. Sponsors and Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS) Principal Investigators:
Wayne Feng, MD, MS
Medical University of South Carolina
Gottfried Schlaug, MD, PhD
Beth Israel Deaconess Medical Center and Harvard Medical School