Vagus Nerve Stimulation Improves Depression When Other Treatments Fail

November 24, 2017 · Posted in Current Treatments · Comment 

VNSVagus nerve stimulation (VNS) has been approved by the US Food and Drug Administration as an adjunctive therapy for treatment-resistant unipolar and bipolar depression since 2005. The treatment consists of a pacemaker-like device implanted under the skin in the chest that delivers regular, mild electrical pulses to the brain via the left vagus nerve.

A 2017 study by Scott T. Aaronson and colleagues in the American Journal of Psychiatry reports that over a 5-year period, people with treatment-resistant depression who received VNS did better than those who received treatment as usual. The 795 participants at 61 US sites had either a depressive episode that had lasted for at least two years or had had three or more depressive episodes and had failed to respond to at least four treatments, including electroconvulsive therapy (ECT). Over five years, those who received VNS had higher response rates (67.6% versus 40.9%) and higher remission rates (43.3% versus 25.7%) compared to those who received treatment as usual.

While the study by Aaronson and colleagues was non-blind and non-randomized, it suggests that VNS could be helpful in the long-term management of treatment-resistant unipolar and bipolar depression.

Editor’s Note: VNS was FDA-approved for treatment-resistant seizures in patients aged 12 and older in 1997 and for children 4 years and older in 2017. It was also approved for cluster headaches in 2017. Insurance coverage and reimbursement for VNS is typically available for these neurological conditions, but not for the treatment of depression. This is an unfortunate example of the stigmatization of psychiatric illness—when an FDA-approved device can be kept from people in need of treatment.

Easier Vagal Nerve Stimulation Via the Ear

August 30, 2016 · Posted in Potential Treatments · Comment 
vagal nerve stimulation

Vagal nerve stimulation is typically delivered via a stimulator in the chest wall.

Vagal nerve stimulation (VNS) is an FDA-approved treatment for seizures and treatment-resistant depression. It typically requires an operation to insert a stimulator in a patient’s chest wall that delivers electrical impulses to their left vagus nerve via electrodes placed on the patient’s neck. New research by Bashar W. Badran and colleagues may have identified a less invasive and less expensive way to stimulate the vagal nerve—via electrodes placed on the ear.

The researchers tested different parameters for vagal nerve stimulation via the ear on 15 healthy volunteers and found that this type of VNS was feasible, tolerable, and reasonably safe. Among the different parameters tested, a stimulation pulse width of 500 microseconds at 25Hz had the greatest effect on heart rate, slowing it by about 4.25 beats per minute compared to a sham treatment.

Next Badran and colleagues plan to study the effects of this type of VNS on brain activity using functional magnetic resonance imaging (fMRI).

Over 5 Years, Vagal Nerve Stimulation Better than Treatment as Usual for Severe Depression

July 10, 2015 · Posted in Potential Treatments · Comment 

vagal nerve stimulationVagal nerve stimulation (VNS) is an FDA-approved treatment for both seizures and depression that has resisted other treatments. It requires an operation for the insertion of a stimulator in the chest wall and electrodes on the left vagus nerve in the neck. A new study by Scott T. Aaronson and colleagues presented at the 2015 meeting of the Society of Biological Psychiatry observed severely depressed patients, 494 who received VNS and 301 who received treatment as usual in the community, over a period of five years. The patients who received VNS had greater response rates, they were more likely to have experienced remission, and their remissions lasted longer than those who received treatment as usual. Overall the patients who received VNS had lower mortality rates and suicide rates as well. VNS might be a good option for patients with depression that has not responded to most other treatments.

VNS Covered For Reimbursement For Refractory Epilepsy But Not Refractory Depression

October 8, 2013 · Posted in Current Treatments · Comment 

VNSThe federal Centers for Medicare and Medicaid Services (CMS) appear to discriminate against people with psychiatric illness. They will not approve the use of VNS (Vagus Nerve Stimulation) for treatment resistant depression among Medicare beneficiaries but have approved it for refractory epilepsy.

Vagus nerve stimulation consists of electrical stimulation of the vagus, one of the cranial nerves. The Federal Drug Administration (FDA) has already approved VNS for both illnesses, meaning that it has been judged to be effective and safe in both.

The CMS decision will make it harder for poor patients to access this treatment because it means that Medicare will not reimburse the cost of the treatment.

Cyberonics, the company that manufactures the device used to provide VNS, applied for CMS approval of the use of VNS for depression in 2007 and was rejected, but hoped that the research collected in the intervening years that shows VNS’s efficacy in treatment-resistant depression would be enough to get eventual approval from CMS. They have been rejected again.

Editor’s Note: The data supporting VNS’s efficacy in epilepsy are skimpy and without a large effect size, so it cannot be argued that the quality of data supporting the coverage of VNS for depression is the reason it hasn’t been approved for that purpose. Both epilepsy and depression can be devastating and life altering.  To support the use and reimbursement for the same FDA-approved device for one but not the other illness seems worthy of protest.

This appears to be another example of the incongruous use of FDA approval status to deny coverage. Insurance companies and government agencies routinely use lack of FDA approval to deny reimbursement claims for many commonly used drugs and treatments, while at the same time, in cases such as the use of VNS, actual FDA approval is disregarded and considered an insufficient criterion. Having it both ways does not seem to bother the policy makers who appear to put the financial bottom line ahead of ethics, fairness, and good medical care.