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Neurostar® Efficacy

Clinical trials have demonstrated the effectiveness of NeuroStar® TMS Therapy in treating patients who have not benefited from prior antidepressant medication. NeuroStar TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.

An Effective Option for Treating Major Depressive Disorder

In a study where 307 patients received active treatment (similar to a real clinical context), as well as a 12 month follow up, over half of the patients treated with NeuroStar TMS Therapy experienced significant improvement in their depression symptoms. About a third of the patients treated with NeuroStar TMS Therapy experienced complete symptom relief at the end of six weeks. The study consisted of 307 available unipolar, non-psychotic MDD patients in acute phase.¹

Patients treated with NeuroStar® also experienced significant improvement in anxiety and physical symptoms (such as appetite changes, aches and pains, and lack of energy) associated with depression.¹

Additionally, Neuronetics has developed a new tool to use in educating patients on the best practices of treating depression. The Best Practices Treatment Guideline for Depression has been developed to help patients understand TMS Therapy as an option if their first line antidepressant medications stop working. This guideline is based on the 2010 American Psychiatric Association's practice guidelines and NeuroStar TMS Therapy indication for use, which says:

NeuroStar TMS Therapy is indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

Please see the Treatment Algorithm for an effective illustration of the use of NeuroStar TMS Therapy early on in the treatment of depression.

NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Its effectiveness has also not been established in patients that have failed to receive benefit from two or more prior antidepressant medications at minimal effective dose and duration in the current episode.

View TMS Therapy safety data

References:

1. Demitrack, MA, Thase, ME. Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant depression: synthesis of recent data. Psychopharm Bull. 2009, 42(2): 5-38.

Neurostar® Safety

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

Treatment with NeuroStar TMS 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 TMS Therapy 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 TMS Therapy 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 TMS Therapy 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 TMS Therapy 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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