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BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder
Globenewswire· 2025-11-17 12:30
Core Viewpoint - BrainsWay Ltd. has launched a multicenter clinical trial to evaluate its next-generation Deep TMS 360™ technology for treating Alcohol Use Disorder (AUD), which affects approximately 29 million Americans and has a high relapse rate among patients [1][3]. Group 1: Clinical Trial Details - The trial will be randomized, double-blind, and sham-controlled, enrolling over 200 patients aged 18–86 with moderate to severe AUD based on DSM-5 criteria [3]. - Participants will receive either active or sham treatments for about six months, with an intensive treatment phase in the first 3–5 weeks, followed by weekly maintenance sessions [3]. - The primary endpoint is the proportion of participants with no heavy drinking days during the initial four-month treatment period, a measure recognized by the FDA as clinically meaningful [3]. Group 2: Technology Overview - The new Deep TMS 360 technology is designed for more comprehensive and uniform stimulation of targeted brain regions, potentially addressing challenges in treating complex clinical populations like those with chronic AUD [2]. - The multichannel architecture of the system may enhance stimulation levels, particularly in patients with cortical atrophy [2][4]. Group 3: Company Perspective - The CEO of BrainsWay emphasized the significance of this trial in addressing a major public health challenge and the potential of the new technology to aid patients in overcoming alcohol dependence [3]. - The Vice President of Medical Affairs highlighted the study's potential to advance understanding of noninvasive neuromodulation in reducing alcohol cravings and promoting long-term recovery [4]. Group 4: Research Locations - The study will be conducted at multiple research sites across the US, including states like Alabama, California, Florida, Illinois, New York, and West Virginia, as well as select international sites in Israel and Sweden [4].