Brainsway Deep TMS Therapy - for Brain Disorder Treatment

Final Results – Autism Trial at the Alfred Hospital, Melbourne, Australia

Sunday, November 11, 2012

11 November, 2012

Further to that stated in the Brainsway® periodic report for 2011 with regard to the clinical trial exploring the possible beneficial effects of the Company’s Deep TMS device on the theory of mind and social communication skills of adults with autism or Asperger syndrome, the Company is pleased to report the final results that were received from the Monash Alfred Psychiatry Research Centre in Melbourne, Australia.

The results indicate a marked improvement in social communication skills and a clear reduction in social-related anxiety levels in subjects that received REAL Deep TMS treatment with the Company's device, compared to control subjects who received SHAM TMS stimulation.

The final results were obtained from 28 subjects (out of 30 who participated in the trial): 4 subjects with autism, and 24 with a diagnosis of Asperger syndrome. The trial followed a double-blind placebo-controlled design, with subjects divided into two groups – one which received REAL Deep TMS treatment, and one that was treated with a SHAM TMS coil.

Autistic symptoms were assessed before treatment, immediately after treatment, and again one month after the conclusion of treatment. Subjects were scored on the Ritvo Autism Asperger Diagnostic Scale (RAADS), the accepted rating scale for evaluating symptom severity in adults with autism spectrum disorders. Analysis of test scores indicates that subjects who received actual Deep TMS treatment experienced a marked and statistically significant (p=0.019) improvement in their social communication skills one month after the end of treatment compared to their pre-treatment (baseline) scores. Furthermore, the results indicate a trend of improvement in symptoms between the end of treatment and the follow-up evaluation performed one month later. Analysis of results for the control group did not reveal any significant difference in scores on the RAADS.

Subjects' verbal communication and sensorimotor abilities were also assessed before and after treatment, but no discernible differences were observed. The investigators take this as an indication that Deep TMS acts primarily on subjects' social communication skills.

In addition, immediately after treatment, subjects in the REAL Deep TMS treatment group exhibited a near-significant (p=0.057) improvement in scores compared to baseline on a scale used to rate anxiety levels during difficult situations that call for social communication. At the next assessment one month later, improvement in scores on this scale reached significance (p=0.004). No such improvement was found in the control group.

According to the investigators, these results provide initial evidence that treatment with the Company's Deep TMS device can improve social communication skills in adults with autism spectrum disorders. The Company and its researchers are currently exploring possibilities for conducting additional clinical trials of the device in this population.

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