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. The FDA cleared BrainsWay D treatment of Major Depression in patients who failed to respond to one or more anti-depressants in the current episode.
1 March 2014
University of Toronto, Faculty of Medicine, Centre for Addiction & Mental Health, Canada
We propose a pilot study to investigate the efficacy and safety of the Brainsway H-coil deep brain rTMS in the treatment of patients with treatment resistant anorexia nervosa (TrAN), targeting the insula. The general objective of this study is to investigate the neurological pathways implicated in AN using H-coil deep rTMS. The specific goal is to perform a pilot study to test the safety and tolerability of repeated H-coil TMS as a potential treatment for TrAN. Also, if the safety and tolerability of deep H-coil rTMS stimulation is demonstrated in this study, this modality may be useful as a potential treatment strategy for individuals with AN. If both efficacy and safety are demonstrated, then a properly designed randomized controlled trial with deep H-coil rTMS compared to sham rTMS treatment will be implemented to investigate the possible therapeutic effects of H-Coil deep rTMS stimulation.
It is hypothesized that the Brainsway® H-coil deep rTMS will be a safe treatment approach for patients with TrAN. We also propose that such subjects will show behavioral and physical improvement in AN following deep rTMS treatment, in addition to improvement in co morbid symptoms of depression, anxiety and obsessionality.
Assessment instruments will be administered in all phases of the project, including pre-assessment (baseline), treatment phase after the deep rTMS procedure (6 weeks), maintenance phase (6 weeks); post-treatment (the end of the 12th week), and following 1st and 6th months after treatment.
Contact: Yuliya Knyahnytska, MD, MSW Tel: 416-535-8501, ext. 34648
Principal Investigator: Allan S Kaplan MSc MD FRCP(C)