Are there any safety concerns or side effects from the treatment?

Side effects following Deep TMS 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:

• Site pain (25%).
• Site discomfort (19%).
• Jaw pain (10.2%).

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 Deep TMS treatment:

• Headaches (47% in treatment group, 36% in sham group). Such headaches tend to get better or go away completely with successive treatments, and can be alleviated using over-the-counter medication.
• Muscle twitching (6% in treatment group, 1% in sham group).
• Back pain (4% in treatment group, 8% in sham group).
• Anxiety (5% in treatment group, 7% in sham group).
• Insomnia (7% in treatment group, 7% in sham group).

Possible Deep TMS Side Effects following OCD 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 Deep TMS treatment:

• Headaches (32% in treatment group, 35% in sham group).
• Anxiety (12% in treatment group, 3% in sham group).
• Jaw pain (8% in treatment group, 1% in sham group).
• Common cold (8% in treatment group, 9% in sham group).
• GI symptoms (8% in treatment group, 0% in sham group).
• Diarrhea (6% in treatment group, 1% in sham group).
• Neck pain, 4% in treatment group, 5% in sham group).
• Fatigue (2% in treatment group, 9% in sham group).

General Safety Concerns

Individuals who fall under the following categories should not undergo Deep TMS Treatment:

• Patients with magnetic metal plates or devices implanted in or around their heads (this does not include standard amalgam dental fillings).
• Patients with implanted electronic devices in their bodies.
• Patients who have undergone a seizure, a medical condition or change in a medical condition that may put them at increased risk of having a seizure.

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 Deep TMS is appropriate for them:

• Patients who have a suicide plan or have recently attempted suicide.
• Patients who do not meet DSM criteria for the relevant mental health condition.
• Patients less than 18 years of age or older than 68 years of age.
• Patients with a history of substance abuse.
• Patients with a psychotic disorder, such as schizophrenic disorder, schizoaffective disorder, bipolar disease, or major depression with psychotic features.
• Patients with psychoses or with psychiatric emergencies where a rapid clinical response is needed, such as immediate suicide risk.
• Patients with neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma or with primary or secondary tumors in the CNS.
• Patients with metal in or around the head, including metal plates, aneurysm coils, cochlear implants, ocular implants, deep brain stimulation devices, and stents.
• Patients with implants controlled by physiological signals, including pacemakers, implantable cardioverter defibrillators, and vagus nerve stimulators.
• Patients who are pregnant or nursing.