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Vagus Nerve Stimulation
For Treating Depression

Vagus Nerve Stimulation may be the possible successor to ECT (Electroconvulsive Therapy). In July 2005, the VNS Therapy System was approved by the FDA for depression patients who have run out of treatment options despite controversy on whether it even works.

In July 2003, Cyberonics, which manufactures the VNS device, announced that the Vagus Nerve Stimulator is effective in treating severe, treatment-resistant depression. That followed completion of a 235-patient clinical study of the safety and efficacy of vagus nerve stimulation (VNS Therapy) in patients with chronic or recurrent depression in the United States and Canada. In the study, subjects had a pacemaker-like pulse generator, called the VNS Therapy System, implanted under the skin in the upper left chest. A stimulation electrode connected to the generator is tunneled from the chest to the neck where it is attached to the left vagus nerve.

Previously, Cyberonics conducted a 60-patient pilot study of the safety and efficacy of the vagus nerve stimulation (VNS Therapy) in patients with chronic or recurrent depression. Results of the acute phase of the study indicated substantial improvement. In an abstract from the study, researchers say "positive open trial results in a severe, treatment-resistant depression patient group suggest that VNS is a safe and effective treatment for a significant proportion of these patients."

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One news report cites Lauri Sandoval, 42, a participant in the pilot study, who has tried almost every antidepressant available and was set to start electroconvulsive therapy: "I was so desperate and depressed that I wasn't even scared of it, even though it hadn't been studied before."

Lauri had suffered from depression for 30 years and was having trouble holding down a job. It took her three months after receiving the implant to feel the change, and 18 months later, she reported feeling dramatically better:

"I used to be a hermit and I tried to pretend that I wasn't depressed. I would stay in bed as long as I could. I would get up to go to work, or to walk my dogs, but after a while that would even be difficult."

It's important to remember though that these studies in depression are investigational (experimental) and the safety and efficacy of VNS in the treatment of depression has not been established.

Another potential drawback may be the cost involved. The VNS device costs $12,000 and the cost of surgery to implant the device can run as high as $15,000. One day, insurance companies may find this is more cost-effective than antidepressant medication or talk therapy over the long term, but some say they won't be quick to pick up the tab.

Background

Vagal nerve stimulation was initially developed and approved by the FDA for the treatment of refractory partial onset epilepsy. Recently, it has been reported that VNS in patients with epilepsy is associated with an improvement in mood. As a consequence, VNS has also been investigated as a treatment for refractory depression (treatment resistant depression). The potential antidepressant effect of VNS has been reported to be most effective in patients with low-to-moderate, but not extreme, treatment-resistant depression. The most common adverse effect associated with VNS is voice alteration or hoarseness. Vagal nerve stimulation has not been reported to cause cognitive impairment.

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Regarding the use of VNS for the treatment of refractory depression, Rush, et al. (2000) reported on an uncontrolled case series involving 30 adults with treatment-resistant major depressive disorders who underwent a 10-week trial of VNS. A positive response, defined as at least a 50% decrease in baseline score of the Hamilton Depression Rating Scale, was noted in 40% of patients. Currently, the manufacturer of the NeuroCybernetic vagal nerve stimulator device has sponsored a clinical study of the safety and effectiveness of VNS in patients with depression.

Because of the lack of well-designed controlled clinical trials, VNS for refractory depression is considered experimental and investigational. Long-term data regarding tolerability as well as symptomatic and functional outcomes of depressed patients receiving VNS are needed to ascertain the effectiveness of this procedure for treating refractory depression.

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