Program Director:      Dr. Timea Hodics
                                    Assistant Professor of Neurology

Transcranial Direct Cortical Stimulation (tDCS)
Enhanced Stroke Recovery and Cortical Reorganization

Purpose
Primary: To test the hypothesis that transcranial Direct Current Stimulation (tDCS) applied in combination with standard rehabilitative training (RT), will enhance motor recovery 3 months after admission in stroke patients relative to placebo and RT.
Secondary: To evaluate if functional recovery is associated with changes in cortical excitability in the ipsilesional primary motor cortex (M1) and dorsal pre-motor cortex.

Design
Randomized, double-blind controlled clinical trial.

Patient Involvement
Eligible patients with weakness in their arm and or hand, within 15 days of their stroke will be randomized either in rehabilitative training (RT) transcranial Direct Current Stimulation (tDCS) or in RT placebo stimulation for 1 hour daily, Monday through Friday for 10 weekdays. tDCS will be applied for first 20 minutes of simultaneous rehabilitative therapy. A subgroup of patients will undergo functional MRI (fMRI) and transcranial magnetic stimulation (TMS) testing.
Healthy volunteers and chronic stroke patients will not participate in the interventional component of the study. They will only participate in testing the experimental paradigm for TMS and fMRI.

Primary Outcome
The primary endpoint is improvement in the Fugl-Meyer motor scale at 3 months.

Transcranial Direct Current Stimulation (tDCS)
In Chronic Stroke Recovery - Pilot

Purpose
To collect pilot information for a subsequent larger clinical trial for the best type of transcranial direct current stimulation (tDCS) in cortical and subcortical strokes and to help evaluate expected effect size in this subsequent larger study.

Design
Randomized, order cross-over, double-blind controlled clinical trial.

Patient Involvement
The first exploratory phase involves chronic stroke patients (stroke more than 3 months ago) to undergo 4 different type of tDCS stimulation, including sham stimulation, concurrently with 1 & ½ hours of physical therapy on each therapy day.
In the second phase of the experiment we will perform only the promising stimulation paradigms plus sham from the first part of the experiment simultaneously with 1 & ½ hours of physical therapy in a random, counterbalanced order. The patient time commitment in the second phase is 12 weeks, where subjects will have 4 x 2 weeks long treatment sessions (10 weekdays) with 1 week inter-treatment “rest period”.

Primary Outcome
First phase: Improvement in upper extremity maximum force, reaction time, motor function test at the end of each session.
Second phase: Improvement in motor scale at the end of each intervention and at 1 week follow-up.