Dr. Aron Tendler, Chief Medical Officer at BrainsWay, presented the data in an oral presentation entitled, “Smoking Cessation Induced by Deep Magnetic Stimulation: A Double-Blind Sham Controlled Multi-Center Study,” which took place today, Saturday, March 14, 2020, from 10:45-11:00 AM CT.
“Tobacco smoking is one of the primary causes of preventable death and also leads to other serious conditions, such as cancer and heart disease,” said Dr. Tendler. “While there are several treatment options currently available, the development of other therapies is critical to increasing the continuous quit rate among smokers. Findings from our multicenter study indicate that Deep TMS could potentially serve as a treatment option for inducing smoking cessation. BrainsWay is proud to be at the forefront of non-invasive brain stimulation for addiction and we are focused on working to make Deep TMS available to patients attempting to successfully quit smoking as expeditiously as possible.”
The results presented are from a randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of Deep TMS treatment as an aid in reducing cigarette smoking in individuals suffering from chronic smoking addiction. The trial was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible subjects randomized into two groups: an active treatment group treated with BrainsWay’s proprietary H4-coil targeting addiction-related brain circuits, and a sham (placebo) control group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate (CQR), representing abstinence during a consecutive four-week period.
Of the 168 participants in the study who actually completed three weeks of active Deep TMS or sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.4% in the treatment group compared to 11.7% in the sham group (p=0.0063). The primary endpoint was defined based on the CQR among those subjects who received at least one Deep TMS (or sham) treatment session and had at least one post-baseline assessment, even if not completing the treatment period. Within this cohort (which consisted of 234 participants and included dropouts) the CQR was 19.4% in the treatment group and 8.7% in the sham group (p= 0.0174).