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NeuroStar Advanced Therapy TMS Safety

Clinical trials have demonstrated the safety of NeuroStar Advanced Therapy® in treating patients who have had an inadequate response to prior antidepressant medications.

Treatment with NeuroStar Advanced Therapy caused very few side effects and was generally well tolerated by patients. The most common side effect reported during clinical trials was scalp discomfort—generally mild to moderate and occurring less frequently after the first week of treatment.

Fewer than 5% of patients discontinued treatment with NeuroStar Advanced Therapy TMS due to adverse events.

Over 10,000 active treatments were performed across all NeuroStar® clinical trials demonstrating its safety1

  • 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 drug interactions
  • NeuroStar Advanced Therapy TMS should not be used in patients with implanted metallic devices or non-removable metallic objects in or around the head. This does not include metallic fillings in teeth.
  • NeuroStar Advanced Therapy TMS should not be used in patients with implants controlled by physiological signals. This includes pacemakers, implantable cardioverter defibrillators (ICDs), and vagus nerve stimulators (VNS).

Learn about a typical NeuroStar Advanced Therapy TMS treatment session.

References:

  1. 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.

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Indication

NeuroStar Advanced Therapy is only available by prescription. A doctor can help decide if NeuroStar Advanced Therapy is right for you. Patients’ results may vary.

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Visit neurostar.com for full safety and prescribing information.

Important Safety Information

The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of TMS therapy (<0.1% per patient).

NeuroStar Advanced Therapy should not be used with patients who have non-removable conductive metal in or near the head. NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.