Revolutionizing Alcohol Use Disorder Treatment
BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ: BWAY), a renowned leader in noninvasive brain stimulation technologies, has announced a significant advancement in mental health treatment. The company is initiating a multicenter clinical trial aimed at evaluating the effectiveness of its innovative Deep TMS 360™ system for individuals struggling with Alcohol Use Disorder (AUD). This condition impacts approximately 29 million Americans, highlighting an urgent public health concern.
The Challenge of Alcohol Use Disorder
Alcohol Use Disorder poses not just a personal struggle but also a broad economic challenge, with about 10% of those aged 12 and older affected by this debilitating condition. Although several treatment options exist, relapses remain frequent, with as many as 60% of patients experiencing a return to heavy drinking within just a few months of treatment. As such, developing new, effective therapies is crucial in combating this widespread issue.
Introducing Deep TMS 360™ Technology
BrainsWay's newly developed Deep TMS 360 technology is designed to offer a sophisticated approach to brain stimulation. This advanced system is equipped with a multichannel architecture intended to optimize stimulation across various targeted brain regions. The design aims to address the challenges faced by patients with AUD, particularly those whose neuroanatomy may complicate treatment efficacy due to factors like brain shrinkage.
A Novel Clinical Trial Approach
The upcoming clinical trial represents a pioneering effort utilizing BrainsWay's next-generation technology and will enroll over 200 adult participants, all diagnosed with moderate to severe AUD based on DSM-5 criteria. The randomized, double-blind, sham-controlled study will span approximately six months and involves an intensive treatment phase in the first month, followed by weekly maintenance sessions for the remaining duration.
Key Study Parameters
The study's primary focus is to determine the proportion of patients who achieve what is termed no heavy drinking days (NHDD) during the initial four-month treatment period—an endpoint recognized for its significance in clinical research concerning AUD. Alongside the TMS treatments, participants will receive behavioral and educational sessions aimed at promoting coping strategies and reducing alcohol consumption.
Expert Insights on the Study
Dr. Colleen Hanlon, Vice President of Medical Affairs at BrainsWay, comments on the potential impact of the Deep TMS 360 system: “This technology could represent a meaningful evolution in our treatment offerings, promoting considerable progress in reducing alcohol cravings and facilitating long-term recovery for individuals.” Such advancements reflect the company's commitment to exploring transformative solutions for mental health challenges.
Conducting the Study
The trial is set to take place across various research sites throughout the US and select international locations, underscoring the extensive reach of BrainsWay's clinical initiatives. Previous studies into BrainsWay’s traditional Deep TMS system have yielded encouraging results, laying the groundwork for this innovative exploration.
Participating in the Trial
Individuals interested in potentially enrolling in the trial can find additional information through BrainsWay's official channels, as they work to build a pool of participants ready to explore new avenues for recovery.
About BrainsWay
BrainsWay is at the forefront of advanced neurostimulation treatments for psychiatric disorders. The company has established itself as a pioneer in this field, with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform leading the way in improving mental health outcomes. With a strong track record of securing FDA-clearances supported by rigorous clinical investigations, BrainsWay is dedicated to advancing its mission of improving patient health and transforming lives through cutting-edge technology.
Frequently Asked Questions
What is the objective of the Deep TMS 360 clinical trial?
The trial aims to evaluate the efficacy of the Deep TMS 360 system in treating Alcohol Use Disorder by reducing heavy drinking days in participants.
How many participants will be involved in the trial?
Over 200 participants aged 18 to 86 with moderate to severe AUD will be enrolled in the study.
What treatments will participants receive?
Participants will receive either active Deep TMS 360 treatment or sham treatment, along with educational and behavioral support concerning alcohol use reduction.
What does the term 'no heavy drinking days' mean in the study?
No heavy drinking days (NHDD) refers to the absence of days where participants engage in heavy drinking during the four-month treatment period, which is a significant measurement for the study.
How does BrainsWay contribute to improving mental health?
BrainsWay leads in developing advanced neurostimulation technologies that address various mental health conditions, boasting a strong clinical foundation of proven efficacy.
