Stroke Rehabilitation – Double-Blind Placebo Control Safety and Feasibility Study


Hadassah Medical Organization, Jerusalem, Israel

1 March, 2009

A clinical trial using Brainsway®’s Deep TMS device for the rehabilitation of stroke patients has begun.

The trial is designed determine the safety and efficacy of deep transcranial magnetic stimulation (TMS) in treating acute ischemic stroke (stroke resulting from a blood clot in the brain).

Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves a magnetic field to obtain images of the brain.

All participants will receive standard medical and rehabilitation therapy for stroke. In addition, patients recruited for the study will receive several sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Sessions will begin on day 3 after stroke onset and will be given on an alternate day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from the hospital, or until day 17, whichever is earlier. Assessments will include physical examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate both the response to treatment and side effects if needed. Patients will return for a follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery rate and functional status.