This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. The FDA cleared BrainsWay D treatment of Major Depression in patients who failed to respond to one or more anti-depressants in the current episode.
Ichilov Medical Center, Tel-Aviv, Israel
25 May, 2009
The Purpose of the clinical trial is To evaluate the efficacy of Brainsway® Deep Transcranial Magnetic Stimulation (Deep TMS) with an improved H-coil, which targets deep brain structures, in the treatment of Alzheimer’s patients concomitantly treated with drugs to which they previously failed to respond, or responded only partially.
The Target population of the research study is 45 men and women aged 50-85 with Alzheimer’s disease. The Duration of the clinical trial is 16 weeks for each subject (3 weekly treatment sessions for the first 4 weeks; one weekly session for the latter 4 weeks). A follow-up visit, at which no additional treatment will be administered, will take place 8 weeks after the treatment period.
Study outcome measure is the cognitive response to treatment defined as an improvement of 3 or more points on the ADAS-cog scale at the conclusion of 16 weeks of treatment.
Contact: Adi Shabi +(972) 03-6973698, firstname.lastname@example.org
Principal Investigator: Dr. Ellisa Ash