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 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 for treating bi-polar disorder episodes, took place at the Shalvata Mental Health Center, Hod-Hasharon, Israel.
Brainsway Ltd. announces the final results of a clinical trial utilizing the Company’s Deep TMS device for the treatment of Bipolar Depression (Manic Depression) in subjects that did not respond to medication, as such results was presented in a conference on the matter that was held in Germany. The trial was performed in Shalvata hospital in the framework of a collaborative effort between the Company and the hospital, and its objective was to investigate treatment utilizing the Company’s Deep TMS device.
The final results of the trial are based on the Shalvata Principal Investigator’s final report, following receipt of results in respect of 20 participants.
According to the findings of the Final Report, all subjects took the treatment well, and 70% of the subjects responded to the treatment (a vast majority of same with significant improvement) as compared with previous treatment with anti-depressants that were given to the subjects (fig. 1).
The extent of the effect of the Company’s Deep TMS device on the subjects in the trial was explored using various criteria for the rating of depression, including the Hamilton Depression Rating Scale (HDRS), a questionnaire that measures the severity of depression, and others.
The Hamilton Depression Rating Scale (objective) showed that treatment with the Company’s Deep TMS device resulted in a substantial statistical improvement in subjects at the trial’s completion (as compared with its commencement) (fig.2) , and such findings correspond with the subject reports (subjective) that were assessed utilizing the Beck Depression Inventory, which similarly showed a substantial statistical improvement in subjects at the trial’s completion (as compared with its commencement) (fig. 3).
According to the Final Report, an assessment of the subject’s cognitive functions also showed a substantial improvement (fig. 4).
The trial that is the subject of the Final Report is the first in its field. In order to prove efficacy, additional comparative trials will be required with a control group, the next of which is expected to be held at Shalvata hospital and at the Johns Hopkins hospital in the United States with a sham group, with 50 participants. The Company has already received approval from the Helsinki Committee of Shalvata hospital for such trial, and is awaiting approval of the Medical Devices Department of the Ministry of Health.
Figure 1. Treatment response and remission
Figure 2. The effect of Deep TMS on HDRS score
Remark: *** = p<0.001
Figure 3. The effect of Deep TMS on BDI score
Figure 4. The effect of Deep TMS on cognitive functions (figures 4a, 4b, & 4c):
Figure 4a. The effect of Deep TMS on cognitive functions (SWM)
Figure 4b. The effect of Deep TMS on cognitive functions (SRM)
Figure 4c. The effect of Deep TMS on cognitive functions (PAL)