A new study by the University of Alabama at Birmingham is using a device originally developed to treat seizure disorder to treat patients with treatment-resistant depression.
Vagus nerve stimulation therapy consists of a small — about the size of a quarter — device implanted just below the collarbone that sends out mild pulses to a nerve in the neck.
It was approved in 2005 as a safe and effective treatment option for use in difficult-to-treat depression but has not been widely used, due to a lack of reimbursement from payers.
Matthew Macaluso, D.O., and study coordinator Katlyn Jackson, from the UAB School of Medicine’s Department of Psychiatry and Behavioral Neuroscience, are participating in a national study assessing the results of VNS Therapy® in individuals whose depression continues despite trying four or more treatments.
“When the VNS device started being used for seizure disorders, doctors noticed that their patients seemed to feel happier,” Macaluso said. “This was due to the device’s stimulating the vagus nerve, which increases activity in the frontal cortex, helping patients with their mood.”
Macaluso says the study may provide evidence that Medicare and other insurance companies need in order to cover it, making the device more accessible to this group of patients with difficult-to-treat depression.
The procedure to implant the device is an outpatient procedure, and most patients can be expected to go home the same day.
Macaluso is partnering with UAB’s Nicole Bentley, M.D., assistant professor in the Department of Neurosurgery, for the implantation of the device.
“Because depression is so hard to treat, and there are not many options for medicines, I hope to see real improvement in the severity of the depression for at least half of our patients,” Bentley said. “If at least half see an improvement, that would be a big win. If just one sees improvement, that would still be a win in my book.”
Those eligible to participate in the study include Medicare patients with four antidepressant treatment failures in a depressive episode. The most common side effects of the VNS device include voice changes such as hoarseness, prickling or tingling in the skin, sore throat, and breathlessness, and these tend to improve over time. The most reported side effect from the implantation procedure is infection, which occurs less than 1 percent of the time.
The UAB study site, one of 50 nationwide, is recruiting 37 patients to participate. If you are interested in joining the study, contact Katlyn Jackson at katlynjackson@uabmc.edu or
205-975-6426.
