Supplement to TRANScranial direct current stimulation for POst-stroke motor Recover - a phase II sTudy (TRANSPORT 2)

Duke University, Durham NC

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Abstract

Abstract Stroke remains a leading cause of disability with motor deficit being the most common complication after stroke. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has been shown to promote and enhance brain plasticity and to modulate the excitatory and inhibitory interhemispheric imbalance that developed after a stroke. TRANScranial direct current stimulation for POst-stroke motor Recovery - a phase II sTudy (TRANSPORT 2) is an ongoing multi-center stroke recovery study on the NIH StrokeNet. The primary aim of this proposal is to determine whether there is an overall treatment effect among the three dosing groups (sham+mCIMT, 2 mA+mCIMT and 4 mA+mCIMT) immediately after 2- week intervention in the Fugl-Myer Upper-Extremity Scale (a measure of motor impairment). Additional outcome measures include the Wolf Motor Function Test Time Score (a measure of functional motor activity), and the Stroke Impact Scale Hand Subscale (a measure of the quality of life). The sustained benefit is assessed at 1 month as well as 3 months post-intervention. Secondary aims will assess safety, tolerability, and feasibility to implement this combined approach in a multi-site trial. An exploratory aim will examine whether weighted corticospinal tract- lesion load (wCST-LL, structural assessment of integrity of descending motor tract) or Motor Evoked Potentials (MEPs, functional assessment of integrity of descending motor tract) or a 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 future confirmatory Phase III study. The study is ongoing and is its final year of funding period. The recruitment has reached nearly 75%. However, due to a 3-month shutdown of StrokeNet during Covid19 and subsequent slow-than- expected site reactivation, we project to finish subject enrollment with existing funding. This non- competing administrative supplement is to provide additional cost to cover the enrolled subjects' follow-up and data analysis period for this study.