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.
BrainsWay’s Deep Transcranial Magnetic Stimulation (dTMS) is a safe and noninvasive therapy that is FDA cleared to treat OCD and MDD. The treatment process may cause some relatively minor and passing side effects. Several studies on Deep TMS have shown it to be a safe treatment with no lasting, substantial or systemic side effects, all of which can be caused by medication. Specifically, side effects such as weight gain, dry mouth, sexual problems, or memory effects were not observed in patients following treatment. No longer-term effects were observed during a three-month follow-up. Individuals considering Deep TMS should discuss the treatment with their doctor to determine if it is right for them, and whether any precautions should be taken before or during treatment.
The following side effects should be considered when deciding whether to include Deep TMS treatment in a patient’s treatment course:
Individuals undergoing Deep TMS treatment may experience some mild discomfort during the process itself, with some individuals reporting a tapping sensation in the targeted area.
Side effects following dTMS procedures are normally quite mild. A multicenter, randomized clinical trial for Major Depressive Disorder (MDD) found that the most common side effects observed after Deep TMS treatment include:
The following side effects were not significantly different in the treatment vs. sham (placebo) groups, and as such were not found to specifically be caused by the dTMS treatment:
The following side effects were observed in patients with Obsessive-Compulsive Disorder (OCD) during a prospective, double-blind, randomized, controlled, multicenter study. No significant differences were seen between the treatment and sham groups, suggesting that these side effects are not specifically attributable to the magnetic stimulation of the brain involved in dTMS treatment:
Individuals who fall under the following categories should not undergo dTMS Treatment:
The safety and effectiveness of Brainsway’s Deep TMS have not specifically been established in the following patient populations through a controlled clinical trial. Patients included in these groups should speak with their mental health provider to assess whether dTMS is appropriate for them: