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.
A clinical trial of studying the feasibility of using the Deep TMS H System in augmentation of antidepressant drugs, for the treatment of resistant depression, took place at the Hadassah Ein-Kerem Medical Center, Jerusalem, and Be’er Ya’akov Mental Health Center, Israel.
The trial found treatment using the Company’s device in conjunction with antidepressant drug therapy to be safe and effective.
The trial was performed concurrently at the Hadassah Medical Center and the Be’er Ya’akov Mental Health Center, by Dr. Moshe Isserles (the “Principal Investigator”), and included 56 subjects with drug-resistant depression. The trial’s final results are based on the final report by the Principal Investigator. For more details concerning the trial, please see the Company’s prospectus, and its immediate report filed on February 18, 2008.
The extent of the effect of the Company’s Deep TMS device on patients was assessed using various depression scales, such as the Hamilton Depression Rating Scale (HDRS), the Beck Depression Inventory – a self-report questionnaire used to rate the severity of depression, and other scales.
The treatment was well tolerated by most patients. A few patients reported mild headaches, particularly during the first treatments. These headaches resolved quickly. A single occurrence of an epileptic seizure in one patient should be noted. The seizure terminated spontaneously, leaving no residual effects, and was likely triggered by a combination of especially high doses of antidepressant drugs in that patient.
45 patients who completed at least 10 treatment sessions exhibited a significant increase of 13 points in their mean Hamilton Depression scores, and of 10 points in their mean Beck Depression Inventory scores. 22 patients (49%) responded significantly to the treatment (exhibiting a greater than 50% improvement on the Hamilton Rating Scale), and 13 patients (29%) achieved full clinical remission.
In conclusion, the results of this study demonstrate that Deep TMS (transcranial magnetic stimulation) in conjunction with antidepressant drug therapy is safe and effective.
It is of note that the remission rates reported in the literature for third- and fourth-line drug therapies in the study population are low (approximately 13%). According to the findings of the final report, the rate of remission in this study was significantly higher: approximately 30%.
In light of the favorable results of this study and the recommendations of the Principal Investigator, the Company is considering conducting a broader-scope, double-blind study.