BrainsWay MDD Treatment Safety Information

When Should the BrainsWay Treatment be Used?

The BrainsWay Deep TMS System is indicated for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

When Should the BrainsWay Treatment Not be Used?

TMS Therapy delivers a magnetic field that could cause any metal objects that are near the device to move or to get hot. DMTS Treatment should not be used if you have metal implants in or around your head (except for standard amalgam dental fillings). TMS treatment should not be used if you have implanted electronic devices in your body. These implants could cause serious injury or death if TMS treatment is used. You should tell your doctor if you have any metal devices or objects in your head or body in order to determine if those devices could be affected by the Deep TMS Treatment.

Safety Information

Safety of the BrainsWay’s Deep TMS System was demonstrated in a clinical study involving 233 patients with moderate to severe Major Depressive Disorder. The patients ranged in age from 22 to 68 years.

This section summarizes the adverse events and side effects reported in the clinical study with the BrainsWay Deep TMS System.

• There were no deaths in patients who took part in the clinical trial.
• Systemic side effects such as weight gain, dry mouth and sexual problems were not observed.
• Tests of memory function during treatment showed no change during the clinical trial.

You should discuss the warnings and precautions related to the Deep TMS Therapy with your doctor to determine if any precautions should be taken prior to or during your treatment with BrainsWay Deep TMS System.

Seizures

There was one case of a seizure (also called convulsions) reported in the clinical study with the BrainsWay Deep TMS System. This seizure was due to high alcohol consumption the night before treatment. 3 more seizures (out of approximately 50,000 treatment sessions) were reported in other studies with the BrainsWay Deep TMS System in subjects on high doses of antidepressants, which are known to increase the risk of a seizure. None of the subjects who have experienced Deep TMS-induced seizure have suffered lasting physical sequelae.

You should discuss with your doctor if you have had a seizure, or if you have a medical condition or change in a medical condition which may put you at increased risk of having a seizure, e.g., brain injury, change in medications, change in electrolyte balance, etc. Your doctor will decide if it is appropriate for you to receive BrainsWay Deep TMS Therapy.

Worsening of Depression or Suicidality

Your antidepressant medications may be tapered down prior to the BrainsWay Deep TMS Treatment. You may feel uncomfortable or be unable to tolerate the tapering of medications. Your depression may become worse before you begin to see an improvement in your symptoms. Increased mood lability and suicidality may also result from tapering medications. BrainsWay TMS Therapy may require several weeks of treatment before symptom improvement occurs.

Your doctor will monitor you for worsening depressive symptoms or signs or symptoms of suicidal behavior during the course of the treatment. You should also inform your doctor if you have any behavioral changes, such as worsening of depression, suicide attempts and ideations, increased aggressiveness, euphoria or irritability. Your family and caregiver should also be aware that if such behavioral changes appear, they should inform the treatment administrator immediately. Your doctor will determine whether BrainsWay TMS Treatment should be discontinued and, if so, what other treatment options are available.

Long-Term Safety

The long term safety of the BrainsWay Deep TMS Treatment has been demonstrated in a clinical study. During the full course of 16 weeks of ongoing treatment, the treatment was safely tolerated. Furthermore, no negative effects of treatment were seen during a 3 month follow-up period. Longer term effects of exposure to the TMS Therapy are not known. However, exposure to other devices (such as MRI scanners) with the same type and strength of magnetic fields produced by the BrainsWay Deep TMS coil are not associated with significant short-term or long-term safety concerns.

The safety and effectiveness of the BrainsWay Deep TMS System has not been established in the following patient populations or clinical conditions through a controlled clinical trial:

• Patients who have had no prior antidepressant medication failure.
• Patients who cannot tolerate withdrawal of antidepressant medications.
• Patients who are concurrently taking antidepressant medications.
• Patients who have a suicide plan or have recently attempted suicide.
• Patients who do not meet DSM IV criteria for major depressive disorder.
• Patients less than 22 years of age or older than 68 years of age.
• Patients with history of substance abuse, obsessive compulsive disorder or post-traumatic stress disorder.
• Patients with a psychotic disorder, including schizoaffective disorder, schizophrenic 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 with major depressive disorder who have failed to receive clinical benefit from ECT or VNS.
• Patients who are pregnant or nursing.

During treatment with the Deep TMS System a loud clicking sound is emitted. Patients must use earplugs with a rating of at least 30 dB of noise reduction. There have been no reports of hearing loss with the TMS Therapy in the clinical study when earplugs were used.

Adverse Events

Application site pain or discomfort was reported in 25% and 29% of patients who received the BrainsWay Treatment, and in less than 1% and 4.1% of the patients who received the sham (placebo) treatment. Pain in jaw was reported in 10.2% of patients who received the BrainsWay Treatment, and in less than 1% of the patients who received the sham treatment. This indicates that these side effects are caused by the BrainsWay Treatment.

You should inform the treatment administrator if you feel pain or discomfort during the treatment. The Deep TMS helmet may be slightly adjusted on your head to relieve the pain or discomfort. Pain and discomfort associated with treatment usually gets better or goes away altogether with successive treatments.

Headaches were reported in 47% of patients who received the BrainsWay Treatment, and in 36% of the patients who received the sham (placebo) treatment. This indicates that headaches were not necessarily caused by the BrainsWay Treatment. Headaches usually get better or go away altogether with successive treatments. Headaches may also be relieved by using common over-the-counter pain medications such as acetaminophen.

Other side effects which may occur but are not necessarily caused by the BrainsWay Treatment include muscle twitching, back pain, anxiety or insomnia.