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.
Deep Transcranial Magnetic Stimulation (dTMS) is operated by trained professionals who follow strict regulations to ensure the patient’s safety. As a noninvasive procedure, dTMS is a safe, proven and effective therapy course with relatively minor and passing side effects. That said, you should discuss dTMS with your doctor to determine if it is right for you and whether any precautions should be taken prior to or during treatment.
Individuals undergoing Deep TMS treatment may experience mild discomfort during the procedure itself, with some reporting a tapping sensation in the targeted area. Generally speaking, side effects following dTMS procedures are normally quite mild.
For Major Depressive Disorder (MDD), the most common side effects observed in our multicenter randomized clinical trial during treatment include:
The following side effects were not significantly different in the treatment vs. sham (placebo) groups, and therefore may not be specifically caused by dTMS treatment:
In a prospective, double-blind, randomized, controlled, multi-center trial on dTMS effects on patients with Obsessive-Compulsive Disorder (OCD), the following side effects were observed. No significant differences were seen between the treatment and sham groups, suggesting that these side effects may not be specifically attributable to the magnetic stimulation of the brain involved in dTMS treatment.
It should also be noted that 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 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 should speak with their mental health provider in these cases to assess if dTMS is appropriate for them: