Israel-based medical device company Brainsway has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to evaluate the efficacy of its Deep TMS device in multi-center smoking cessation study.
The FDA has granted the IDE approval based on its determination that the study is a non-significant risk study.
With this approval, Brainsway has outlined its plans to start the execution of a double-blind, multi-center study to measure the efficacy of its Deep TMS device in inducing smoking cessation using a specialized coil developed for this purpose.
The study expects to recruit around 220 patients in ten medical centers in the US, Europe and Israel.
The trial subjects will be divided into sham treatment group and real stimulation treatment group.
The primary outcome measure for therapeutic efficacy will be the change in cigarette consumption levels by the patients, as measured both by self-report and by urinary cotinine levels at the end of the treatment period, and again six months after the end of treatment using only self-report.