NeuroStar TMS Therapy, a Non-Drug Depression Treatment, Demonstrates Statistically Significant Benefits on Patient-Reported Pain Outcomes
Study Participants Experienced Improvement in Pain and Well-Being that Persisted Through One Year
SAN DIEGO, March 19, 2013 – New data released today at the annual meeting of the American Academy of Neurology show that transcranial magnetic stimulation (TMS) administered using the NeuroStar TMS Therapy System® significantly reduced pain-related symptoms in patients with Major Depressive Disorder (MDD), with improvement sustained through one year. Pain-related symptoms are present in more than 75 percent of patients living with depression, indicating a need to offer patients effective treatment options.
“A majority of people living with depression experience pain-related symptoms, which often interfere with patients’ quality of life and may result in greater treatment costs,” said Dr. Mark George, M.D., Director of the Brain Stimulation Laboratory at Medical University of South Carolina. “The data in this preliminary study indicate that TMS may serve as a promising, effective, non-drug option to relieve symptoms of moderate to extreme pain in patients with MDD without the systemic side effects of oral medications.”
In this subset analysis of a Neuronetics-sponsored multisite, naturalistic, observational study involving 42 TMS clinical practice sites based in the United States, 307 outpatients with a primary diagnosis of MDD were treated with NeuroStar TMS Therapy and received an average of 28 TMS sessions during acute treatment. Investigators evaluated improvement in pain measures using two quality of life instruments, the EuroQol Questionnaire (EQ-5D) and the Short Form 36-Item Questionnaire (SF-36).
At baseline, 47.1 percent of patients indicated moderate pain and discomfort while 11.7 percent of patients indicated extreme pain and discomfort, which decreased significantly by the end of acute treatment to 41.4 percent and 6.6 percent of patients, respectively. The improvement in the percent of patients reporting extreme pain and discomfort was sustained through 12 months of follow-up, demonstrating durability in the most extreme pain cases.
The percentage of patients reporting general pain-related problems significantly reduced from 58.8 percent at baseline to 48 percent at the end of acute treatment, as measured by the EQ-5D. In addition, the SF-36 bodily pain scores improved significantly following acute NeuroStar TMS Therapy from 44.5 to 48.1, which persisted through 12 months. There was a significant correlation between the improvement of the SF-36 bodily pain scores and the improvement of depressive symptomatology, as measured by the Patient Health Questionnaire (PHQ-9).
About NeuroStar TMS Therapy ®
Neuronetics’ NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD). NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. 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. The treatment is available by prescription and typically administered daily for 4-6 weeks. For full safety and prescribing information, visit www.NeuroStar.com.
Depression is a serious illness that affects about 20 million Americans annually. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems. It is estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts.
About the Study
This study was designed to assess patient-reported pain outcomes following Transcranial Magnetic Stimulation (TMS) treatment for major depression disorder (MDD) in clinical practice. Three hundred and seven depressed patients were part of a prospective, multi-site, observational clinical trial studying the utilization and outcomes of the NeuroStar TMS Therapy system in naturalistic clinical practice. Patients who received benefit from acute TMS treatment (N= 257) consented to long-term follow up over 12 months, and were evaluable for statistical analysis. The objectives of the study were to assess the change in depressive symptomatology and functional capacities across the duration of the study. Data for the pain domains in the Short Form 36-Item Questionnaire (SF-36) and the EuroQol Questionnaire (EQ-5D) were collected at baseline, end of acute treatment (EOA), 3-, 6-, 9-, and 12-months follow-up, in order to evaluate the effect of NeuroStar TMS therapy on pain in patients with MDD.
About Neuronetics, Inc.
Neuronetics, Inc., is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation. For more information, please visit www.neuronetics.com.
NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of Neuronetics, Inc.
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