Vagus Nerve Stimulator
http://www.cerbomed.com/transcutaneous-Vagus-Nerve-Stimulation-88.html
Anyone looking into transcutaneous Vagus Nerve Stimulation devices (tVNS) such as Nemos by Cerbomed should consider that this devices is simply an expensive TENS unit. The 4000 dollar device is based off of studies that used a standard TENS unit($150 on Amazon) to stimulate the auricular branch of the vagus nerve distributed to the skin of the ear(Clancy et al., 2014). This is simply done by placing the TENS electrode on the tragus of the ear. The electrical signal given to participants was (200 microseconds @ 30 Hz). Besides that fact that Nemos is expensive, it is also only approved in 3 European countries and is not available in the United States. I think it is unlikely that our POIS study will use Nemos, most likely they will just be using a modified TENS unit that fits and stays on the tragus.
Although Cerbomed states that Nemos is safe(this is a non-invasive device), invasive surgically implantable vagus nerve stimulation devices have been associated with much higher rates of cardiac death. Stimulating the vagus nerve causes a change in heart rate variability, this not recommended without supervision by a medical professional.
Anybody interested in learning more about TENS units to stimulate the Vagus nerve should read these articles:
1) University of Leeds. "'Tickling' your ear could be good for your heart." ScienceDaily. ScienceDaily, 19 August 2014. <www.sciencedaily.com/releases/2014/08/140819200211.htm>.
ANDS ALSO the original study below by Clancy et al. 2014
2) Jennifer A. Clancy, David A. Mary, Klaus K. Witte, John P. Greenwood, Susan A. Deuchars, Jim Deuchars. Non-invasive Vagus Nerve Stimulation in Healthy Humans Reduces Sympathetic Nerve Activity. Brain Stimulation, 2014; DOI: 10.1016/j.brs.2014.07.031
http://www.brainstimjrnl.com/article/S1935-861X%2814%2900260-5/abstract
Article by Dr. Lauracostis
There is a reason that Dr, Komisaruk has been approved by the IRB. and that it took so long. These approvals aren't taken lightly, and they have, more than anything, our safety in mind.
Approved TENS devices are approved for specific applications. I imagine it could be very dangerous to use a device that is used for pain mitigation in joints and muscles for a delicate procedure like vagus nerve stimulation. Most TENS devices have "programs" and protocols, and specific electrode configurations. Some applications are "simple", others are very complex.
What make the TENS unit useful for any application, is the combination of factors that make it up. Most of these are controlled by firmware (internal software), but ultimatley come from medical expertise, research and knowledge.
I really don't care which unit Dr. Komisarul will use. If he uses the cheapest he can find, I don't have a problem, it's his knowledge in the choice and application, that I trust.
He has been doing this work and using devices like this for longer than any of us here. He is doing it in combination with careful study of the supposed patient (subject) and careful follow-through, which even includes an fMRI. Most cheap units don't come with an fMRI.
It's Dr. Komisuruk's protocol and follow-through that interest me.
