Israel-based medical device company Brainsway has obtained an investigational device exemption (IDE) clearance from the US Food and Drug Administration (FDA) to initiate a clinical trial for assessing the efficacy of its Deep TMS (transcranial magnetic stimulation) device in treating patients suffering from obsessive-compulsive disorder (OCD).
The double-blind study is expected to be conducted at approximately 15 medical centers in the US, Europe and Israel. The multi-center trial is expected to enroll approximately 100 OCD patients.
The trial subjects will be divided into two groups, including a sham treatment group and a real stimulation treatment group.
The FDA has granted IDE approval based on its determination that this is a non-significant risk study. Accordingly, Brainsway intends to act quickly in order to initiate the study following receipt of the requisite Investigational Review Board approvals.
Brainsway is developing a medical device for the treatment of common brain disorders. The noninvasive device is based on a uniquely shaped electromagnetic coil connected to a rapidly changing current supply, which produces magnetic fields capable of affecting different areas of the brain.
Depending on the frequency of the magnetic field, the deep brain areas can be either excited or inhibited.