New Device To Be Tested On Patients With Major Depression

Wake Forest Baptist will be one of 16 centers participating in the national clinical trial to compare TMS with a "sham" treatment in patients with major depression.

Smaller preliminary studies have indicated that TMS has an antidepressant effect, but this larger, more rigorous trial is necessary to better understand the strength of the effect and gain U.S. Food and Drug Administration (FDA) clearance for use, said Peter Rosenquist, M.D., principal investigator at Wake Forest.

“If cleared by the FDA, TMS could be a significant new weapon for doctors to offer patients fighting depression,” he said. 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.

Rosenquist, associate professor of psychiatry and behavioral medicine, explained that the sham treatment is needed because some patients improve simply because of the added attention they get in a research study, the so-called placebo effect. Comparison with the sham treatment will confirm whether TMS really works.

The new trial, involving 286 patients nationally, will be a pivotal trial, and if the results are positive, the data will be submitted to the U.S. Food and Drug Administration for approval of TMS as a treatment for major depression.

Rosenquist said that neither doctor nor patient will know whether the actual TMS is being used. The sham device looks, acts and sounds like the real thing.

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

The magnetic pulses easily pass through the skull and into the brain. Inside the brain, Rosenquist said, the magnetic pulses produce an electric field, which can cause positive changes in mood. Patients remain fully awake during the 45 minute outpatient TMS procedure and can immediately go back to their normal daily activities.

“The amount of electricity created in the brain is kept small enough to minimize the risk of adverse effects,” Rosenquist said. Those effects sometimes include headache and, in rare cases, a seizure.

A similar Transcranial Magnetic Stimulation device is already in use for brain mapping, diagnosis of neurological diseases and research into a number of neurological and psychiatric conditions.

Rosenquist said that typical ways of treating major depression include antidepressants and other pharmaceuticals, electroconvulsive therapy, and several methods of psychotherapy. The study will focus on those patients who have not responded to several trials of antidepressant medications.

“We are excited to be participating in this landmark research for a new antidepressant,” Rosenquist said.

The study is being sponsored by the manufacturer of the TMS equipment, Neuronetics, a medical device company headquartered in Malvern, Pa.