Honolulu, Hawaii — In an open-label study of patients with major depressive disorder (MDD) who had not benefitted from prior antidepressant medication and were treated with Neuronetics' NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy, no negative effects in cognitive function were observed following six-month follow-up. Approved by theFDA in October 2008, NeuroStar 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. It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly focused MRI-strength magnetic field pulses. Treatment is typically administered daily for four to six weeks. In 2009,
Neuonetics provided data that demonstrated the system's ability to improve key areas of cognition in patients. Presented on April 14 at the American Academy of Neurology, findings from the new study (conducted in 120 MDD patients) compared the long-term effect of acute treatment with NeuroStar TMS on patients' cognitive function to the cognitive function of patients given acute sham treatment. "Depression often causes cognitive disturbances in patients. Antidepressant medications can have, as a side effect, an impact that can further worsen patients' cognition," said Scott Aaronson, MD, director of Medical Research Services at Sheppard and Enoch Pratt Hospital in Maryland. "TMS provides an effective treatment option for depression without harm to cognition."
Results of the six-month follow-up study comparing patients who had received NeuroStar TMS Therapy or sham treatment showed no deterioration on any measure of cognition. In addition, there was no negative effect on cognition in patients who received reintroduction of acute NeuroStar TMS during the six-month period.
Specific measures of global cognition (Mini Mental Status Examination), short-term (Buschke Selective Reminding Test) and long-term (Autobiographical Memory Interview-Short Form) memory were obtained at 24-week follow up from patients with MDD who received acute TMS treatment (N=99) compared to patients with MDD who were given acute sham treatment (N=21).
These patients had participated in a randomized, controlled study of four to six weeks of acute NeuroStar TMS Therapy (N=155) as compared to sham treatment (N=146)
1. In that study, no cognitive effects were reported after acute NeuroStar TMS Therapy
2. "We are pleased with these new results on long-term cognitive function. These data support the growing body of evidence that NeuroStar TMS is a safe option for patients with major depressive disorder," said Mark A. Demitrack, chief medical officer for Neuronetics. "Neuronetics is committed to continuing our research to find lasting non-pharmaceutical treatments to address this potentially debilitating disease."
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- O'Reardon, J.P., Solvason, H.B., et al. (16 June 2007). Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression: A Multisite Randomized Controlled Trial. Biological Psychiatry. 1 December 2007 (Vol. 62, Issue 11, Pages 1208-1216).
- Janicak, P.G., O'Reardon, J.P., et al. (2008, February). Transcranial Magnetic Stimulation in the Treatment of Major Depression: A Comprehensive Summary of Safety Experience from Acute and Exposure and During Reintroduction Treatment. Journal of Clinical Psychiatry.