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.
University of Toronto, Faculty of Medicine, Centre for Addiction & Mental Health, Canada
20 March 2013
Depression is a prevalent illness in late-life and it contributes to functional morbidity and mortality. Up to 84% of patients treated for late-life depression (LLD) either do not respond to treatment or respond and then relapse. Pharmacological strategies for managing treatment resistance in the elderly are problematic due to higher sensitivity to medication adverse effects and drug-drug interactions. Electroconvulsive therapy (ECT) has an excellent track record in treatment-resistant late-life depression (TRLLD). However, many patients refuse treatment with ECT due to social stigma and the risk of marked memory impairment. Over the past decade, deep transcranial magnetic stimulation (Deep TMS) has been shown to be effective and well tolerated for treatment-resistant depression (TRD) in younger adults. However, only few studies, with limited sample sizes, have evaluated Deep TMS for TRLLD. Some studies have concluded that older age predicts inferior outcome, due to the presence of prefrontal cortical atrophy, a common finding in older patients with LLD. The inferior outcomes can be explained as follows: the magnetic field produced by the standard rTMS figure-8 coil provides only superficial cortical stimulation. In the presence of age-related prefrontal atrophy, the distance from the scalp to the cortex increases and the magnetic field cannot penetrate the cortex deep enough to produce therapeutic effects. Brainsway® Ltd. has developed a patented Deep TMS coil called the H-Coil that provides far greater depth of penetration. This H-Coil has the potential to overcome age-related prefrontal atrophy and to stimulate brain structures involved in LLD. We propose to assess the efficacy and tolerability of H-Coil Deep TMS in TRLLD using a randomized-controlled trial. The proposed research could have a major impact on TRLLD, a significant and growing public-health problem in Canada and the Western world.
Contact: Daniel M. Blumberger MD, MSc, FRCPC Tel: 416-535-8501 x 33662
Principal Investigator: Daniel M. Blumberger MD, MSc, FRCPCZ. Jeff Daskalakis MD, PhD, FRCPC