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.
Brainsway is pleased to announce its final results from a clinical trial of the Company’s Deep TMS device for the treatment of auditory hallucinations in schizophrenic patients. The trial was performed at the Be’er Ya’akov Mental Health Center in the framework of a collaboration between Brainsway, the Be’er Ya’akov Mental Health Center and the Medical Research Fund of the Assaf Harofeh Hospital.
The trial results described in the principal investigator’s report are based on the results of 8 patients, three of whom received the treatment twice (i.e., a total of eleven cases were assessed). In light of the favorable results of the trial, the principal investigator has decided that the trial be discontinued at this stage, in order to progress to the next stage of clinical testing, i.e. a double-blind, sham stimulation-controlled multicenter trial.
The extent of the beneficial effect of the Company’s Deep TMS device on patients was assessed using different assessment scales, as follows:
1. Hoffman’s Auditory Hallucinations Rating Scale (AHRS), which assesses the frequency and number of voices heard, how “real” they seem, their intensity, the extent to which they affect the patient’s behavior, their duration, and the level of distress they cause the patient. This is the primary scale whereby the treatment’s efficacy was evaluated.
An average improvement of 37% was observed in scores obtained using this scale
2. The Scale for the Assessment of Positive Symptoms (SAPS) in schizophrenia, which measures auditory hallucinations, among other symptoms.
An average improvement of 33% was observed in scores obtained using this scale
3. The Clinical Global Impression (CGI) scale, which assesses the general severity of mental illness.
According to this scale, the average severity of illness among the trial participants was categorized as ‘Markedly Ill’ before the trial. Following the series of treatments administered in the trial, the average severity of patient illness became ‘Moderately Improved’, and in some cases, ‘Full Improvement’ was even observed.
4. A greater than 50% improvement in functioning levels was reported by relatives or independent staff members at hostels (Global Assessment of Functioning).
5. All patients reported improvement in mood, although this finding was not verified by assessment scales as it was not anticipated based on previous studies employing superficial magnetic stimulation. Improvements in cognitive function were also recorded.
According to the principal investigator’s report, in one of the patients, who had experienced auditory hallucinations for years with no relief from medication, and who had heard voices continuously throughout the day prior to the treatment, the voices stopped entirely after the second treatment, and did not recur before the time the report was written (a period of 4 months).
The principal investigator’s report ends with the estimation that despite the need to corroborate the trial results in a sham stimulation-controlled study, the researchers are confident in the effectiveness of the treatment, owing to the fact that patients, of their own accord, have asked to come back for a longer series of treatments.
As mentioned previously, in light of the favorable results of the study, the Company has decided to progress to the next stage of clinical testing and perform a double-blind, sham stimulation-controlled multicenter trial.