What is NeuroStar TMS Therapy?

  • The NeuroStar TMS Therapy system is the first and only TMS Therapy® device cleared by the FDA for the treatment of depression.

  • TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation, which stimulates nerve cells in an area of the brain that is linked to depression, by delivering highly focused MRI-strength magnetic pulses.

  • Patients being treated by NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert.

  • It is a 37-minute outpatient procedure that is prescribed by a psychiatrist and performed in a psychiatrist’s office.

  • The treatment is typically administered daily for 4-6 weeks.


What happens during TMS Therapy? What’s the Mechanism of Action?

  • During NeuroStar TMS Therapy, pulsed magnetic fields are repetitively transmitted into the left prefrontal cortex, the part of the brain that is thought to regulate mood, in order to stimulate the firing of neurons (nerve cells).

  • This is believed to trigger a cascade of neurochemical events, including the release of neurotransmitters (such as serotonin, norepinephrine, and dopamine) and to help normalize neurotransmitter function.


How long does a patient undergo NeuroStar TMS therapy?

  • In clinical trials, patients received NeuroStar TMS Therapy 5 times per week for 37 minutes each session for 4-6 weeks.

  • Patients should be treated for a minimum of four weeks with additional treatments based on clinical judgment.


What are the benefits of NeuroStar TMS Therapy?

  • NeuroStar TMS Therapy is the first and only non-systemic and non-invasive depression treatment to be cleared by the FDA for the treatment of depression

  • It is indicated for adult patients who did not achieve satisfactory improvement from prior antidepressant medication in the current depressive episode

  • In clinical trials, 1 in 2 patients had significant improvement in symptoms and 1 in 3 had complete symptom resolution

  • It is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, sedation, or dry mouth..


How long does the antidepressant effect of NeuroStar TMS Therapy last? Do patients need to go back for another treatment session?

    During the six-month maintenance of effect study with NeuroStar TMS Therapy, patients were maintained on antidepressant monotherapy and received periodic NeuroStar TMS Therapy for symptom worsening. During this study:


  • For patients previously treated with NeuroStar TMS Therapy,less than 10% relapsed at the end of 6 months

  • Approximately half of the patients experienced symptom breakthrough and required TMS Therapy re-treatment.


Is NeuroStar TMS Therapy a good alternative for patients who are fearful of the side effects associated with antidepressant medications?

  • NeuroStar TMS Therapy is the only TMS device that is FDA-cleared, and proven to be safe and effective for the treatment of patients with depression who have failed to achieve satisfactory improvement from prior antidepressant treatment.

  • NeuroStar TMS is non-systemic, which means it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, or sedation.

  • The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.

  • There is a rare risk of seizure associated with TMS Therapy.

  • Not all patients may benefit from NeuroStar TMS Therapy. Like any treatment option, patients and clinicians should work together to find the most appropriate treatment option.


What side effects did studypatients experience during NeuroStar TMS Therapy?

  • The most common adverse event related to treatment was scalp pain or discomfort at the treatment area during active TMS treatments, which was transient and mild to moderate in severity. The incidence of this side effect declined markedly after the first week of treatment.

  • There is a rare risk of seizure associated with TMS Therapy.

  • Less than 5% of patients discontinued the study due to adverse events.


Does NeuroStar TMS cause brain tumors?

  • There is no evidence of these types of magnetic fields causing tumors. TMS Therapy uses the same type and strength of magnetic fields as MRIs, which have been used in tens of millions of patients around the world and have not been shown to cause tumors.

  • The amount of magnetic field exposure for a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.

  • Longer term effects of exposure to NeuroStar TMS Therapy system’s magnetic fields are not known. Experimental and observational evidence indicates that exposure to the type of magnetic fields produced by the NeuroStar TMS System coil does not present any significant risk of acute or longterm adverse effects.


What are the long-term consequences of TMS treatment?

  • TMS is an acute therapy.

  • With regard to long-term safety, TMS uses the same type and strength of magnetic fields as MRIs, which have been used in tens of millions of patients around the world and have not been shown to have long-term consequences.

  • The amount of magnetic field exposure for a full course of TMS Therapy is only a small fraction of one brain scan with an MRI.

  • Longer term effects of exposure to NeuroStar TMS Therapy system’s magnetic fields are not known. Experimental and observational evidence indicates that exposure to the type of magnetic fields produced by the NeuroStar TMS System coil does not present any significant risk of acute or longterm adverse effects.