This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Tobacco smoking is the leading cause of preventable death in developed countries. Smoking is not merely a bad habit, but also a serious addiction. Nicotine, like other drugs of abuse, activates the mesolimbic dopamine system, which originates in the ventral tegmental area (VTA) and projects to limbic areas such as the nucleus accumbens, amygdala and hippocampus. Decreased activity of the brain reward systems during nicotine withdrawal has been closely associated with craving, relapse, and continued nicotine consumption.
For this reason, dopaminergic neurotransmission might serve as a potential target for treating tobacco addiction. Additional support for this hypothesis comes from studies of bupropion, an atypical antidepressant which inhibits neuronal uptake of dopamine, and which has recently been approved as treatment for smoking cessation.
Several standard TMS studies demonstrated a direct effect of single rTMS sessions targeting the dorsolateral prefrontal cortex (DLPFC) on cigarette consumption. A recent study¹ found that 10 days of high-frequency rTMS over the left DLPFC reduced cigarette consumption and nicotine dependence. However, this effect tended to dissipate after the acute treatment. In a follow-up six months later, the reduction in cigarette consumption did not persist and only 12.5% of smokers who responded to the treatment remained in full abstinence
BrainsWay’s treatment offers a promising approach that uses Deep Transcranial Magnetic Stimulation (TMS) for smoking cessation. The treatment performs magnetic stimulation of brain structures and networks related to this addiction and brings significant improvement to patients.
It is an outpatient procedure and does not require hospitalization or anesthesia, is generally well tolerated and entails minimal systemic side effects.
The insula was shown in several recent studies to have a crucial role in craving in several types of addictions including smoking 2-5. The treatment using Deep TMS can directly stimulate the insula as well as deeper PFC structures which are not directly affected with standard TMS.
A recent study [Dinur-Klein et al., In Press] tested the efficacy of Deep TMS over the PFC and the insula bilaterally on smoking addiction in 115 subjects who smoke at least 20 cigarettes per day and failed previous treatment. Subjects were randomized into 6 groups forming 3 Deep TMS stimulation conditions (10 Hz frequency, 1 Hz and sham) with or without presentation of smoking cues prior to Deep TMS sessions.
The best results were found in the high-frequency Deep TMS group that was exposed to smoking cues. In this group the response rate was 81%, the complete abstinence rate at the end of treatment was 44%, and the complete abstinence rate in a follow-up 6 months after the end of treatment was 33%. Urinary cotinine levels were also measured as an objective measure of cigarette consumption and showed significant reduction at the end of treatment in the 10 Hz + cue group, compared to baseline and to the other groups. These results correlated well with self-reported cigarette consumption. The results of this study suggest high-frequency Deep TMS of the PFC and insula in combination with presentation of smoking cue is an effective and durable treatment for smoking addiction.
BrainsWay also recently completed a randomized, double-blind, multicenter study evaluating the safety and efficacy of its system as an aid in reducing cigarette smoking in individuals suffering from chronic smoking addiction, and announced results from the study in December 2019. This trial represents the first multicenter pivotal study conducted with any non-invasive brain stimulation device in the addiction space.
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. Weekly abstinence was defined as a subject’s self-report (in a diary) of no smoking, confirmed by urine tests indicating abstinence from smoking. The participants in the study were highly addicted to smoking, with a history of smoking on average for over 26 years and multiple failed attempts to quit.
Of the 168 participants in the study who actually completed three weeks of H4 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 H4 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).
An important secondary endpoint was the reduction in the number of cigarettes smoked. At baseline, the average number of cigarettes smoked per week was 132 for the active group and 127 for the sham group. After 3 weeks of treatment, the average number of cigarettes smoked per week was reduced to 38 in the active group and 57 in the sham group (p= 0.0018, active vs. sham). By the sixth week of the study, the average number of cigarettes smoked per week declined to 31 for the active group and 48 for the sham group (p=0.0125, active vs. sham).
BrainsWay’s treatment is CE-cleared for treating Smoking Addiction.
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