MALVERN, Pa., April 27 /PRNewswire/ -- Transcranial Magnetic Stimulation (TMS), an investigational noninvasive technique that uses repeated short bursts of magnetic energy to stimulate nerve cells in the brain, has been studied in numerous small clinical research trials. The results from these trials have encouraged researchers that TMS may produce an antidepressant effect. TMS is now being tested at 20 university medical centers and clinical research centers as a potential future treatment for patients with major depression.
"The ongoing clinical trial will include approximately 300 individuals at 20 centers," said Bruce Shook, president of Neuronetics, Inc., the company that developed the TMS device. "More than half of the required study participants have now been enrolled. The study is moving along rapidly and will be completed this year."
Typical ways of treating depression include antidepressants and other medications; electroconvulsive therapy (ECT); and psychotherapy. This study focuses on people who either have failed to benefit from antidepressant medications or have been unable to tolerate the adverse effects of antidepressant medications.
Regulatory Clearance Sought
The clinical trial currently underway is a large, rigorous, controlled trial designed to provide data in support of a regulatory application to the U.S. Food and Drug Administration for marketing clearance of the Neuronetics TMS System for the treatment of depression.
"If it is proven effective, TMS would be an innovative and non-invasive therapeutic option, especially for people who haven't benefited from other therapies," said Shook. "We anticipate seeking FDA approval in 2006."
Trial sites currently enrolling study participants are located in Dallas and Houston, TX; St. Louis, MO; Chicago, IL; Durham and Winston Salem, NC; Ann Arbor, MI; Philadelphia, PA; Palo Alto and San Diego, CA and Charlottesville, VA. Individuals in these areas who believe they may qualify for the study can visit the Neuronetics website, http://www.neuronetics.com/ or call 800-345-8707 for more information, Shook said.
Noninvasive Technique
Researchers believe the left prefrontal cortex is one of the critical components of the brain circuitry involved in regulating mood. Transcranial magnetic stimulation (TMS) produces pulses of magnetic energy that are directly targeted at this part of the brain with the goal of improving the function of these key brain pathways.
The TMS technology creates a high intensity magnetic field with characteristics similar to those produced by standard MRI machines. However, instead of helping doctors look inside the body to diagnose disease, the pulses of magnetic energy produce a stimulus in the brain that researchers believe causes positive changes in mood. The amount of energy delivered to the brain is very small and very focused. Study participants remain fully awake during the 45-minute outpatient procedure and can go about their normal activity before and after the procedure. TMS is performed without anesthesia or sedation, and it does not cause memory loss, as can occur with ECT, or the side effects common with oral antidepressants.
Major Depression - An Unmet Medical Need
The National Institute of Mental Health reports that depression affects more than 18 million adults every year. Even with recent advances in antidepressant medications, a significant percentage of patients experience treatment-resistant or recurrent episodes of depression. Some patients cannot tolerate medications.
This nationwide research study is a pivotal trial. If the results of the study are positive and if the U.S. FDA clears the TMS technology for marketing, an entirely new treatment option for patients suffering from depression would be available for the future.
Who Is Eligible?
Individuals who believe they may qualify for the study are urged to visit the Neuronetics website, http://www.neuronetics.com/, or call 800-345-8707 to locate a research center near their home. To qualify, patients must:
-- Be between 18 and 70 years old.
-- Be suffering from a major depressive disorder.
-- Be able to provide written documentation that they have been
unsuccessfully treated previously with antidepressant medication.
Patients who have been diagnosed with bipolar illness (manic depression) or obsessive-compulsive disorder are not eligible to participate in the trial.
Trial sponsor: Neuronetics, Inc., is a medical device company that is focused on developing non-invasive therapies for psychiatric and neurological disorders using pulsed magnetic fields. For more information on Neuronetics: http://www.neuronetics.com/; info@neuronetics.com; 610-640-4202, ext. 1015.
Neuronetics, Inc.CONTACT: Melissa Nichols, +1-610-640-4528, mncomm@comcast.net, forNeuronetics; or Bruce Shook, Neuronetics, +1-610-640-4202, ext. 1001
Web site: http://www.neuronetics.com/