UMC to Test Device to Alleviate Depression

Kevin Rademacher
Sept. 5, 2000

The University of Arizona College of Medicine is about to test an electronic device researchers say will alleviate suffering in patients with clinical depression.

Of the millions of Americans suffering from clinical depression, experts estimate that more 20 percent experience no relief through existing pharmaceutical treatments. Those patients are left with an uncertain combination of drug, hormone and electroconvulsive treatments, said Francisco Moreno, M.D., assistant professor of psychiatry at the University of Arizona College of Medicine in Tucson.

Vagus nerve stimulation, an effective epilepsy treatment, has produced encouraging preliminary results for patients suffering from "treatment-resistant depression" and a study beginning at University Medical Center and a handful of other U.S. sites may verify the promising new therapy.

UMC, the teaching hospital for the UA College of Medicine, is in the process of selecting 10 study participants from Southern Arizona and the Phoenix area. The patients will be implanted with a NeuroCybernetic Prosthesis (NCP) System, which consists of a battery-powered generator implanted in the chest and a lead attached, at neck level, to the vagus nerve leading to the brain. The device delivers an automatic, periodic electrical stimulation to the nerve. A physician can adjust the intensity, duration and frequency of the stimulation, which may be minimally noticeable by the patient, in follow-up visits.

David Labiner, M.D., associate professor of neurology at the UA College of Medicine, was principal investigator of a UMC study of the NCP system's effectiveness in the treatment of epilepsy in 1994-95. The device received approval for general use in epilepsy treatment by the U.S. Food and Drug Administration in 1997.

"During the epilepsy study we noticed many patients felt better emotionally," Dr. Labiner said.
"Even the patients who did not have a reduction in the number of seizures they were experiencing felt better."

NCP therapy, produced by Cyberonics Inc. of Houston, already has completed an initial study of the depression treatment. The current study could be completed in the next two years at which time the FDA could approve the treatment for general use.

Allan Hamilton, M.D., a neurosurgeon and head of the surgery department in the UA College of Medicine, will lead the surgical team implanting the NCP systems for the study.

Potential patients still are being screened for participation in the study. Those interested may contact the UA psychiatry department at (520) 626-6509. The first procedures to implant the device for the treatment of depression are expected to occur in late September or early October.




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