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Brainsway reports results of 'Deep TMS' clinical trial in PTSD treatment

August 04, 2011

Jerusalem, Israel — Brainsway Ltd., a developer of Deep TMS (Transcranial Magnetic Stimluation) systems, has received the final results of a clinical trial performed at the Hadassah Medical Center to explore the efficacy of Deep TMS in the treatment of post-traumatic stress disorder (PTSD).

The principal investigator of the trial was Dr. Moshe Isserles. The final results are for 26 patients (out of the 30 who enrolled in the trial), receiving at least 8 treatment sessions (the minimum amount required for treatment).

Final analysis of these results has revealed that Deep TMS therapy in conjunction with brief exposure to trauma cues (reminders of a traumatic event, conveyed to the patients through earphones) is safe and effective for the treatment of PTSD.

Subjects were divided into three groups: One group was treated using Brainsway's Deep TMS device together with a brief exposure to trauma cues; a second group received Deep TMS treatment with no trauma cues; and a third group received Sham stimulation with exposure to trauma cues.

The primary measure of treatment efficacy was the change in patients' Clinician-Administered PTSD Scale (CAPS) score (which includes an "intrusive" subscore) at week 5, following treatment. This is the accepted measure of symptom severity in PTSD patients.

In the group that received active Deep TMS treatment with exposure to cues, the mean CAPS score improved markedly from 88 to 61. The mean score of the "Deep-TMS-only" group improved from 87 to 76, and the mean score for the group that received SHAM treatment with exposure to cues improved from 86 to 76. Of these three, only the first group's improvement was statistically significant.

Similar results, at an even higher level of statistical significance, were found for the intrusive CAPS sub-score. Rates of response (defined as a 50 percent or greater reduction in CAPS score) in the three groups were 44 percent, 13 percent and 0 percent, respectively.

Similar improvements in scores were seen on the Hamilton Rating Scale for Depression (PTSD is often accompanied by depression); and on the PSS-SR and BDI-II scales, which are self-report measures for assessing the severity of PTSD symptoms.

Ten patients from the two control groups, who remained symptomatic at the end of treatment, chose to enter the open-label phase of the study, in which they received the same treatment as the treatment group. The mean CAPS score for these patients improved from 87 to 71. Importantly, the clinical improvement experienced by these patients and the patients from the first group (who received active treatment to begin with) was maintained at follow-up evaluations two weeks and two months post-treatment.

In light of these positive results, the researchers propose that a broad multi-center clinical trial be performed, to strengthen and extend the findings of this clinical trial.

The U.S. FDA has confirmed that the regulatory approval process for Brainsway's Deep TMS device for the treatment of major depression disorder (MDD) will be the Pre-Market Notification (510(k)) process.



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