Are brief but intense magnetic pulses delivered to the brain more effective than placebo in treating patients who suffer from depression? A new research study at Emory University and 15 other sites across the U.S. will test the effects of a non-drug therapy called repetitive transcranial magnetic stimulation (rTMS or simply TMS), to determine the effectiveness of this investigational treatment in improving mood.
According to the National Institute of Mental Health (NIMH), major depression is the second leading cause of disability worldwide, behind heart disease. In any given one-year period, nearly 19 million American adults suffer from a depressive illness. Major depression can significantly interfere with an individual's thoughts, behavior, mood and physical health. Most people with a depressive illness do not seek treatment, although the majority -- even those whose depression is extremely severe -- can be helped.
"Treatments for depression include antidepressant medications and psychotherapy," says William M. McDonald, MD, associate professor of psychiatry, Emory University School of Medicine, and J.B. Fuqua Chair in Late-Life Depression. "Patient who don't respond to these treatments may be referred to electroconvulsive therapy or ECT (electroshock therapy). Although ECT is often effective, there is a stigma attached to ECT as well as side effects, such as memory loss. TMS potentially offers an alternative treatment for patients resistant to medications."
About 20 percent of depressed patients do not have a full response to antidepressant medications. In some, the medication becomes less effective after taking it over a period of time. In others, the medication may work effectively, but patients may not be able to tolerate the side effects. Those who fall into this category may be eligible for the transcranial magnetic stimulation study.
TMS is administered through electromagnetic pulses over the left front part of the brain, known as the prefrontal cortex, which is thought to affect mood. A coil delivers the pulses of magnetic energy, which in turn generate electric currents in the brain. In depressed patients, the prefrontal cortex typically exhibits abnormal electrical activity and decreased blood flow. Scientists hypothesize that the stimulation can energize that part of the brain and cause it to function normally again.
Researchers around the world have been testing TMS for almost 20 years in an effort to help understand the circuitry in the brain and how different parts of the brain function. "The unique feature of TMS is that the magnetic stimulation is focused on and directed to one part of the brain," Dr. McDonald explains. "Medications tend to go all over the brain when taken. TMS is helping us to better understand the organization of depression because we target one specific brain region, and in many cases, see positive results."
In this study, participants will have TMS for approximately 35 minutes a day for six weeks (Monday-Friday), followed by three weeks of tapered TMS. Participants will be randomly selected to either receive TMS therapy or an inactive treatment (which will serve as the control group). In a follow-up study, participants who are non-responsive during the initial treatment will have the option to receive active TMS.
Neuronetics, Inc., the maker of the magnetic stimulation machine, is funding this multi-site research study. TMS is not FDA approved and can only be used in an investigational setting, such as this research trial. This study will be followed by another large TMS study for depression, funded by the NIMH. Researchers say this study and others are important stepping stones for a FDA approval process.
To find out more about this study or to enroll, please call Emory Health Connection at (404) 778-7777.