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 D 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.
Two Studies in Italy Explored Deep TMS Effect on Cocaine Desire & Consumption
JERUSALEM – Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced the publication of two studies using Deep TMS therapy for treating Cocaine addiction. Held in Italy, the two studies used H1 coil at a high frequency to bilaterally stimulate the prefrontal cortex, and included 3 weekly treatments over 4 weeks, totaling 12 treatments.
The first study, held by Dr. Paolo Girardi and published in Neuroscience Letters journal, included 7 Cocaine addicts. The treatment was administered in conjunction with existing medication, which had not been modified at least a month before the treatment start and had not generated improvement. The desire level for Cocaine was recorded in a questionnaire before the treatment, once a week during the treatment, and a month after its completion,
The study found a significant and statistically distinct decline in Cocaine desire levels, compared with the preliminary check in the 2nd week (a decline of 49.5% p<0.001), and the 4th week (a decline of 64.6%, p<0.001). The rise in Cocaine desire between the treatment conclusion and the follow-up check was statistically significant (p=0.0003).
The researchers concluded that the treatment is effective for reducing the desire for Cocaine, and suggested that maintenance treatments after the treatment completion could preserve the positive results.
The 2nd study, held by Dr. Marco Diana and published in Frontiers in Psychiatry journal, included 10 Cocaine addicts who were equally divided into real and sham (double blind) groups. The Cocaine consumption of the participants was examined according to the Cocaine level in hair samples taken before and after each treatment, as well as in follow up treatments held 3 and 6 months later.
In this study, no statistically significant difference was found in a direct comparison between the groups. However, such a decline was found in the levels of Cocaine consumption within the group that received real treatment, compared with consumption levels before the treatment. The decline was recorded in the follow-up session – p=0.02 after 3 months, and p=0.01 after 6 months.
The two researcher groups concluded that the improvement achieved in the desire and consumption level is encouraging, and demonstrates the potential of Deep TMS for treating Cocaine addictions. Nonetheless, two researcher groups emphasized that the results were preliminary, and based on small samples, so additional studies are required to establish the treatment efficiency.