Brainsway® Ltd. is pleased to announce that it has received interim results from a clinical trial being conducted at the Sheba Medical Center in Tel Hashomer to explore the efficacy of Deep TMS in the treatment of obsessive compulsive disorder (OCD) patients. The Principal Investigator of the trial is Prof. Joseph Zohar.
Thus far, 9 patients (out of a projected 45) have undergone the clinical trial, which was carried out using a double-blind design. The patients were divided into two groups – one that received REAL TMS stimulation and one that received SHAM stimulation.
40% of the patients in the REAL treatment group responded well to the Deep TMS treatment and experienced an improvement in their condition. No such improvement was observed in the SHAM stimulation control group.
The clinical trial protocol defined clinical improvement as a decrease of at least 35% in symptom severity scores on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a widely accepted scale for assessing OCD. In addition to the magnetic stimulation treatment, patients also underwent repeated EEG recordings, which are considered a reliable and objective measure of the effects of magnetic stimulation treatment. Analysis of these recordings revealed a decrease in pathological brain activity, which was correlated with the clinical variables assessed in the trial.
The treatment was well tolerated by all patients, with no side effects. The investigators noted that although these results are encouraging, they are based on preliminary data and still need to be borne out with a larger sample.