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, or dTMS, is a noninvasive treatment therapy proven to help alleviate mental health illnesses and contribute to a better quality of life. Deep TMS therapy side effects normally do not include any significant discomfort, with patients usually reporting only a mild discomfort. During the dTMS process, the patient can hear a tapping sound and some pressure on the treatment site the dTMS machine is focusing on. The patient is supplied with earplugs to minimize the sound. The dTMS process can also involve some mild pain on the side of the patient’s head, which typically passes once the treatment is over, with most patients not reporting experiencing it later on.
In addition to the above real-time reactions, some mild and passing side effects have been reported by a minority of patients: in a recent BrainsWay study from 2019, patients suffering from major depressive disorder (MDD) who underwent Deep TMS treatment reported experiencing a headache following treatment. A small percentage of patients also reported site discomfort, site pain, jaw pain, lightheadedness, or insomnia following their treatment. While there is a rare risk of seizures to all forms of TMS, it is either less than or comparable to seizure rates experienced with antidepressant medication.
As BrainsWay’s dTMS process is noninvasive, all the equipment involved operates completely outside the body, without penetration of the skin. In cases where the patient experiences local discomfort during the procedure, the dTMS helmet placed over the patient’s head can be adjusted by the system operator to help diminish it.