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 TMS therapy is a non-invasive form of brain stimulation – for the treatment of MDD and OCD – that does not require surgery or implantation of electrodes. It does not require sedation with anesthesia like electroconvulsive therapy (ECT). BrainsWay Deep TMS treatment is performed in an outpatient setting by a physician or trained technician that has been specifically certified to operate the BrainsWay system. Subsequently, BrainsWay’s TMS treatments have been demonstrated to be well-tolerated.
That said, as with all medical treatments there are side effects and risks that patients should consider and be aware of. BrainsWay’s transcranial magnetic stimulation therapy is known to be well-tolerated and does not entail systemic side effects. Only a small percentage of patients discontinue treatment due to TMS therapy side effects. During treatment, patients undergo weekly follow-up visits with their psychiatrist, as well as a daily assessment of side effects by the TMS technician, and complete weekly follow-up measures to assess patient progress.
BrainsWay’s trials demonstrated dTMS to be well-tolerated, safe and effective treatment option for many MDD and OCD patients, with the most common side effects not requiring any special care. The most common transcranial magnetic stimulation side effects are temporary, mild pain or discomfort in the area of the treatment site, typically occurring within the first week of treatment. TMS side effects usually manifest as headaches in about half of patients treated with BrainsWay’s therapy. Those that have been reported are mild and generally diminish over the course of the treatment. Over-the-counter pain medication can be utilized to treat this type of pain.
Other less frequent TMS therapy side effects may include muscle twitching and jaw pain. A small percentage of patients may experience painful scalp sensations or facial twitching due to the deep TMS pulses. These, too, tend to weaken over the course of treatment, and adjustments can be made by the system operator to the helmet’s positioning and stimulation settings so as to diminish discomfort to the patient. While there is a rare risk of seizures associated with all form of TMS, this risk is less than or comparable to seizure rates experienced with antidepressant medication.
It should be noted that BrainsWay’s TMS side effects do not include many of those which are associated with antidepressant medications, including nausea, increased appetite, weight gain, loss of sexual desire, fatigue, insomnia, dry mouth, blurred vision, constipation and more. Furthermore, unlike ECT, patients experience no temporary loss of memory function during or after TMS treatment.
BrainsWay and its licensed medical practitioners follow up-to-date safety guidelines that are designed to minimize the risk of side effects. As stated above, the treatment option is generally well-tolerated but there are always risks to every treatment option. Please contact your physician immediately if you are experiencing anything out of the normal range of side effects during your ongoing treatment with BrainsWay’s therapy.
Please reference BrainsWay’s Patient section for additional information on side effects and adverse events associated with BrainsWay treatment.