Safety
Clinical trials have proven the safety of NeuroStar TMS Therapy in depressed treating patients who have had an inadequate response to prior antidepressant medications.
Treatment with NeuroStar TMS Therapy caused few side effects and was generally well tolerated by patients. The most common side effect reported during clinical trials were headache, scalp pain or discomfort — generally mild to moderate and occurring less frequently after the first week of treatment.
Less than 5% of patients discontinued treatment with NeuroStar TMS Therapy due to adverse events.
Over 10,000 active treatments were performed across all NeuroStar® clinical trials demonstrating its safety:
- No seizures
- No systemic side effects
- No weight gain
- No sexual dysfunction
- No sedation
- No nausea
- No dry mouth
- No adverse effects on concentration or memory
- No device-drug interactions
There is a low risk of seizure with TMS Therapy. The estimated risk of seizure under ordinary clinical use is approximately 1 in 30,000 treatments (0.003% of treatments) or 1 in 1000 patients (0.1% of patients).
Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.
1NeuroStar TMS Therapy should not be used (is contraindicated) in patients with implanted metallic devices or non-removable metallic objects in or around the head. NeuroStar TMS Therapy should be used with caution in patients with implants controlled by physiological signals. This includes pacemakers and implantable cardioverter defibrillators (ICDs).
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References:
- Janicak, P, et al. Transcranial Magnetic Stimulation (TMS) in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry, February 2008.
