Oct. 9, 2008
CHARLESTON -- Millions of patients with treatment-resistant clinical depression, who have struggled for years with disability and how to cope with their condition, now have an option that could help them lead more productive and successful lives.
The NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system, developed by Neuronetics, Inc. and initiated by research at the Medical University of South Carolina (MUSC), is the first and only approved TMS Therapy(r) device cleared by the Food and Drug Administration for the treatment of severe depression. The treatment was approved Oct. 7. Patients must be adults with major depressive disorder, commonly known as treatment-resistant depression, who have failed to improve their condition with other treatments or medication.
MUSC currently is the only location in South Carolina, North Carolina, Virginia, and Florida with this treatment option for depression. Patients will have access to the therapy at MUSC within two months.
MUSC Distinguished University Professor of Psychiatry and Brain Stimulation Laboratory Director Mark George, M.D., played a major role in developing this technology since its beginnings in the late 1980s.
"Everyone in the Brain Stimulation Laboratory has worked so hard for so many years on these studies," he said. "They all deserve credit, as well as many other colleagues who helped to develop the necessary medical equipment to make this therapy a reality. Despite the gloom and doom that seems to surround us, the world is slightly better today than yesterday, as patients with depression have another option to try and relieve their pain and suffering."
George also credited NARSAD (the world's leading charity dedicated to mental health research) with a large role in advancing the new treatment by providing funding and continued support for the first trials involving this kind of treatment.
In addition to the trial that resulted in recent FDA approval, MUSC is also conducting an NIMH (National Mental Institutes of Health) sponsored, double-blind clinical trial for TMS. For more information or to enroll in the trial, visit http://clinicaltrials.gov/ct2/show/NCT00149838.
How it works
TMS Therapy is a non-systemic (does not circulate in the bloodstream) and non-invasive (no 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 treated with NeuroStar TMS Therapy do not require anesthesia or sedation and remain awake and alert. It is a 40-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. In the randomized controlled trial conducted for the FDA, the therapy showed significant treatment effects without systemic side effects such as weight gain or sexual dysfunction.
Throughout the NeuroStar TMS Therapy studies, more than 10,000 active TMS treatments were safely performed with:
• No systemic side effects, such as sedation, nausea, or dry mouth
• No adverse effects on concentration or memory
• No seizures
• No device-drug interactions
• Mild to moderate scalp pain or discomfort at the treatment area during treatment, which declined after the first week of treatment
• A less than 5 percent discontinuation rate due to adverse events
• There were no new safety observations compared to those seen during acute treatment during a 6 month follow-up period
NeuroStar TMS Therapy is contraindicated in patients with implanted metallic devices or non-removable metallic objects in or around the head. As with any antidepressant treatment, patients should be monitored for symptoms of worsening depression. NeuroStar TMS Therapy has not been studied in patients who have not received prior antidepressant treatment. Efficacy has not been established in patients who have failed to receive benefit from two or more prior antidepressant treatments at minimal effective dose and duration in the current episode.
Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 11,000 employees, including 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.6 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children's Hospital and a leading Institute of Psychiatry. For more information on academic information or clinical services, visit www.musc.edu or www.muschealth.com.