TMS NeuroStar

The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. TMS Neurostar was developed and is manufactured by Neuronetics, Inc based in Malvern, PA.

The NeuroStar TMS System is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. The NeuroStar TMS System is used for patient treatment by prescription only under the supervision of a licensed psychiatrist. It can be used in both inpatient and outpatient settings including psychiatrist’s offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.

“Prescription” means that the attending psychiatrist has determined that the use of the NeuroStar is indicated for use in a particular patient, utilizing the FDA-cleared labeling, including benefits and risk of NeuroStar TMS Therapy. In addition to patient selection, the attending psychiatrist should oversee initial patient motor threshold determinations, treatment parameter definitions and overall TMS treatment course planning for each patient. The attending psychiatrist is medically responsible for the routine psychiatric and medical evaluation of the patient during the course of their TMS Therapy treatment.

NeuroStar Safety

Clinical trials have proven the safety of NeuroStar TMS Therapy® in treating depressed patients who’ve 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 effects reported during clinical trials were headache and scalp pain or discomfort — generally mild to moderate and occurring less frequently after the first week of treatment.

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

Food and Drug Administration (FDA) cleared NeuroStar® for treatment of depression in 2008. Read Neuronetics, Inc  press release…

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).

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