חדשות

ה-FDA אישר טיפול בדיכאון ע"י TMS

FDA Approves New Non-Invasive Treatment for Depression Developed by NARSAD Researcher

11.03.2011, 15:41
מנהל התרופות והמזון האמריקני FDA

Magnetic Technology Painlessly Targets Portion of the Brain Most Susceptible to Depression; Available to Consumers in Two Months

(Great Neck, NY - October 20, 2008) — Patients suffering from treatment-resistant clinical depression will soon have access to a new, non-invasive method of treatment using a technique called Transcranial Magnetic Stimulation (TMS), a process developed by NARSAD Scientific Council member Mark S. George, M.D., Distinguished Professor of Psychiatry and director of the Brain Stimulation Laboratory at the Medical University of South Carolina (MUSC).

Approved on October 7 by the U.S. Food and Drug Administration (FDA), TMS involves the use of a magnetic source to stimulate the left prefrontal cortex, an area of the brain that previous imaging studies have proven to be functioning abnormally in people with depression. The treatment will be offered to patients seeking a more effective treatment for major depressive disorder. There are an estimated 14.8 million Americans with the condition.

Dr. George received his first NARSAD grant in 1996 as a Young Investigator, conducting a study among 30 severely depressed patients who either did not respond to medication, or experienced side effects as a result. Twenty patients received 20 minutes of TMS each weekday morning over a two-week period. A control group of 10 patients had the magnet placed on their scalp, but did not receive the treatment. Participants did not know who was receiving the actual treatment.

In the participants receiving TMS, a powerful but painless current produced a magnetic field that passed unimpeded through the skull. The magnetic field, in turn, produced a much weaker electrical current in the brain. Patients felt no pain from the current, but may have experienced some discomfort during a muscle contraction.

The participants receiving TMS showed significant improvement in their depression, according to the study. Using depression rating scales, nine out of 20 patients receiving TMS reported a 50 percent reduction in their symptoms, while no patient in the control group improved. The treatment had no side effects except for a mild headache reported by one-third of the participants, which was relieved by over-the-counter pain medication. TMS did not affect memory.

Dr. George embarked on a new study in 1998 to determine more efficient treatment parameters for TMS in patients, using functional magnetic resonance imaging (fMRI) technology. The findings from his groundbreaking endeavors were ultimately published in a 2003 issue of Biological Psychiatry.

“TMS represents another option for patients,” said Dr. George. “What is perhaps even more important, however, is that it represents a new class of brain stimulation treatments. More research is needed to build on this exciting groundwork, to improve TMS for depression and then use it for other disorders. I am grateful to NARSAD and to the patients who participated in these important clinical trials.”

Patients treated with 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, with treatment typically administered daily for four to six 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.

As a result of Dr. George’s visionary achievements in the pursuit of more effective treatments for depression, NARSAD has named him a recipient of the 2008 Falcone Prize for Outstanding Achievement in Affective Disorders Research.

About Dr. George’s work, Robert M. Post, M.D., chair of NARSAD’s Falcone Prize Selection Committee wrote: Dr. George has made seminal contributions to the development of new, non-convulsive physiological interventions --rTMS (repeated transcranial magnetic stimulation) and VNS (vagus nerve stimulation) -- for the treatment of refractory unipolar and bipolar depression. He has also studied their mechanisms using novel brain imaging techniques and is now applying these technologies to the study of deep brain stimulation for relief of depression as well.

The treatment is being marketed as the NeuroStar TMS Therapy system by Neuronetics, Inc., and will be available to consumers within two months.

נושאים קשורים:  חדשות,  FDA,  דיכאון,  Tms
תגובות