Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. ...Read More
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. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA
24 October, 2010
Further to that stated in Brainsway®’s periodic report for 2009, the Company is pleased to announce that analysis of the results of the clinical trial of the Company’s Deep TMS device for the treatment of the symptoms of blepharospasm (a disorder that affects the eye muscles and causes uncontrolled blinking), reveals that low-frequency Deep TMS treatment using the specialized H-BL TMS coil developed by the Company or using a C-coil (a coil employed in TMS studies), is safe and it leads to immediate alleviation of blepharospasm symptoms. The trial followed a double-blind design with a control group, and was performed by researchers from the National Institute of Neurological Disorders and Stroke (NINDS) research division of the NIH, headed by Dr. Mark Hallett.
The effects of treatment using each of the coils were examined immediately after treatment and again one hour after treatment, with the use of accepted measures for assessing blepharospasm patients.
The researchers note that the trial only explored the immediate effects of a single treatment session, and they propose, in light of its encouraging results, that further studies be performed to explore the long-term effects of repeated TMS treatments.