Denver Scientists Research Magnetic Brain Stimulation for Treatment of Depression

Denver, CO February 25, 2004--Transcranial Magnetic Stimulation (TMS), a non-invasive technique that uses repeated short bursts of magnetic energy to stimulate nerve cells in the brain, is now being tested at Feiger Health Research Center as a potential treatment for patients with major depression.
   
Feiger Health Research Center will be one of 16 centers participating in the nationwide clinical trial to evaluate TMS as a treatment for patients with major depression. Smaller preliminary studies have encouraged researchers that TMS may produce an antidepressant effect. This larger and more rigorous trial will compare the effects of TMS on mood as compared to placebo. The information from this trial will be provided to the US Food and Drug Administration (FDA) to support regulatory clearance of the Neuronetics TMS System for clinical use in the treatment of major depression. If cleared by the FDA, TMS could be a significant new tool for doctors to offer patients fighting the symptoms of depression.

Major depression, which affects an estimated 13 million Americans, is characterized by such symptoms as inability to concentrate, insomnia, loss of appetite, inability to experience pleasure and feelings of sadness, guilt, hopelessness and helplessness. Even with recent advances in antidepressant medications, a significant percentage of patients experience treatment resistant or recurrent depressive episodes or are intolerant of medications.

Alan Feiger, MD, principal investigator at Feiger Health Research Center, explained that this trial involving a sham (or inactive procedure) is needed because some patients improve simply because of the added attention they get in a research study, the so-called placebo effect. The sham procedure design of the trial will confirm if the antidepressant effect of TMS is real and durable. Feiger, said that neither doctor nor patient will know which treatment, the active TMS or the sham, is being used. The sham device looks, acts and sounds like the real thing.
   
This new research study, involving hundreds of patients nationally, will be a pivotal trial for which the resulting data will be submitted to the U.S. Food and Drug Administration to support clearance of TMS as a treatment for major depression. If the results from this study are positive and the TMS procedure is approved by the FDA, this would be the first new procedure for depression since the introduction of electroconvulsive therapy (ECT) was first used in the 1930's.

TMS produces about the same amount of magnetic energy as a standard MRI machine, but instead of helping doctors look inside the body to diagnosis disease as MRI does, the pulses of magnetic energy are aimed specifically at a portion of the brain called the left prefrontal cortex which is thought to be involved with mood regulation.

The nature of magnetic fields allows the special pulses of energy to easily pass through the skull and into the brain. Once inside the brain, Feiger explained, the magnetic pulses produce an electric field, which is thought to cause positive changes in mood. Patients remain fully awake during the 45 minute outpatient procedure and can go about their normal daily activities before and after the procedure. A TMS procedure is in no way similar to an ECT procedure from the patient's perspective.

"The amount of electricity created in the brain is very small and very focused, so as to minimize the risk of adverse effects," Feiger said. "The objective of TMS is to stimulate the "mood circuits" without causing a seizure. Compared to ECT, TMS is relatively benign".
Transcranial Magnetic Stimulation is already in use for brain mapping studies, diagnosis of neurological diseases and for research into a number of neurological and psychiatric conditions.

Feiger said that typical ways of treating major depression include antidepressants and other pharmaceuticals, ECT, and several methods of psychotherapy. The TMS study will focus on those patients who have not responded to several different types of antidepressant medications during efforts to manage their depression.

"We are excited to be participating in this landmark research for a new antidepressant. If proven effective, TMS could be a paradigm shift in how we treat major depression," said Feiger. The study is being sponsored by the manufacturer of the TMS equipment, Neuronetics, Inc., a medical device company headquartered in Malvern, PA. (www.neuronetics.com).

Media Contact:
Feiger Health Research Center
3555 Lutheran Parkway, #320
Wheat Ridge, CO 80033
(303) 425-4298
(303) 425-4303 fax
al@feigerresearch.com




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