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.
Sapienza University of Rome, Italy
26 June, 2011
Further to that stated in Brainsway®’s periodic report for 2010 regarding the double-blinded clinical trial for the treatment of diabetic chronic neuropathic pain that was conducted by Advanced Technologies Innovation Distribution SRL (“Atid”) in Italy using the Company’s Deep TMS device, the Company is pleased to announce the final results of the trial, which was performed on 33 subjects, with each subject receiving a series of REAL treatments over five days, and a series of SHAM treatments over five days. The time gap between these series was 45 days, and the order of REAL and SHAM treatments was randomized.
The results of each series of treatments were assessed with accepted questionnaires for the measurement of pain (such as the visual analogue scale – VAS) and accepted neurophysiological measures for the assessment of pain (for example, RIII reflex and LEP) that were sampled before the treatment, immediately after the treatment and approximately four weeks after the treatment. Analysis of the results indicated a clear improvement in the neurophysiological measures of pain after the REAL treatment. It should be noted that four weeks after the end of the treatment, the improvement was even greater than immediately after the end of the treatment.
The results did not show any improvement after the SHAM treatment.
The principal investigator notes in the report containing the final analysis that the results support the use of the Company’s Deep TMS device for the long-term treatment of patients who suffer from neuropathic pain and who are unresponsive to drug treatment.