Treatment Prospects: Vagus Nerve Stimulation

Here's a quick and nice response from Dr. Kilgard on the development of an enhanced VNS stimulator:

Our current experimental therapy reduces tinnitus severity by about half of people who receive the therapy. We are hoping to do better and are actively working to optimize the therapy.

Unfortunately, it will take at least a year before the new and improved VNS therapy could be approved.

You can track our progress by signing up for our newsletter at https://www.utdallas.edu/txbdc/newsletter/

Best wishes,

Dr. Kilgard

 

My opinion is that surgically implanting a VNS device probably doesn't offer much more than the non-invasive devices routing through other avenues like Lenire going through the tongue. The secret sauce has to do with the simulation parameters, which, as of yet, have shown to be unproven.

 

Is this invasive? Sorry, I haven't kept up with the vagus stimulation treatment research.

 

Yes, it's invasive, but generally considered more safe than other devices like DBS.

 

You may be right @Glenn. It's a questionable matter. Question remains if directly stimulating the vagus nerve via a surgically placed stimulator is more effective than indirectly via the tongue (Lenire). Direct stimulation may be more effective, because it activates the nucleus basalis, which in turn could have a more profound effect on neuroplasticty.

Here's an explanation by Ross about the difference & rationale approach between Lenire and University of Texas/MicroTransponder:

Ross: Right, so there’s also a group in the University of Texas as well. Some of the treatments would target different nerves. Some groups concentrate on the Vagus nerve, so they pair Auditory Stimulation with Vagal Nerve Stimulation because there were a number of papers that showed that a sensory based nerve can activate nucleus basalis which is a key attentional centre and, as I said before, driving attention kind of hardwires the effects into the brain faster so they took that approach. Unfortunately, the only way to access the Vagus nerve is through surgery so it’s a highly invasive procedure. Other devices also target, let’s say the trigeminal nerve, non-invasively but they may do it by stimulating the face or the neck. Now, for us we chose the tongue because, essentially, it’s the most enervated part of the body outside of the fingertip. So, in terms of ‘bang for your buck’ if you’re going to stimulate any nerve that’s the place to do it. Also, the tongue doesn’t have the epidermal layer so it means that you can stimulate it with much, much lower levels of electricity which is much safer.

Link: https://www.tinnitustalk.com/podcas...innitus-talk-podcast-ep07-neuromod-lenire.pdf

 

I really think this research is a dead end and what they're really seeing is the placebo effect. You can actually stimulate the vagus nerve by sticking a q-tip in your ear [1]. When I was younger, I always coughed when I cleaned out my ears and had no idea why until a doctor told me (I don't have a chronic cough though, I only cough when the nerve is stimulated).

If I use a vibrating device on my ear it feels weird, and kind of takes my mind off the tinnitus. It's similar to how HeadOn worked. HeadOn didn't do anything for a headache, but the nice tingly sensation it gave your forehead took your mind off it and made you think it was working in other ways.

The placebo effect is going to make it really hard to find a good treatment for tinnitus. Unless these trials are similar to FX-322 where they only treat one ear, and they test a few weeks after treatment, I would think much of them.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222929/

 

The Texas Biomedical Device Center, closely aligned to University Dallas, has just received FDA approval for two studies by using a new device called the ReStore Wireless Vagus Nerve Stimulator. Momentarily, they are planning to test this on patients with PTSD and spinal cord injury, but this could very well be the device that Dr. Kilgard would use for tinnitus patients.

Here's a video from 2019:

One Device, Unlimited Possibilities with ReStore

More general info, link:
https://www.utdallas.edu/txbdc/technologies/firefly/index.html

More specific info about tinnitus relief, link:
https://www.utdallas.edu/txbdc/technologies/relief/index.html

 

Well it confirms that it is mostly intended for pure tone tinnitus. Has it already come to the market? It is very confusing since this video really looks like an ad. It would be interesting to test this therapy and to design an internal clinical trial like we did for Lenire. I don't know if one of our American fellows signed up to test this stuff. Please let us know.

I guess it is an enhanced version of MicroTransponder (no battery in the chest):

MicroTransponder: Latest News and Research

 

I asked Dr. Kilgard about the current status of the VNS device for tinnitus. Suffice to say that we will not expect anything soon from UT Dallas.

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Dear Dr. Kilgard,

Has there been any developments concerning the VNS/Relief device for tinnitus? I haven't received any notification from the UT Dallas newsletter as of late and I would deeply appreciate it if you have any information about the new treatment.

With kind regards,

Christiaan van R.

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We are not running VNS trials for tinnitus at the moment.

Best wishes,

Dr. Kilgard

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A Potential Treatment for Visual Snow?

Noninvasive Vagal Nerve Stimulation for Visual Snow

Researchers at the Mayo Clinic utilized the theory of cortical hyperexcitability as a mechanism for VS, making nVNS a potential treatment. In this retrospective case series, 3 patients trialed nVNS by performing 2 2-minute stimulations 3 times per day using a gammaCore™ device for 10 to 12 weeks. To evaluate VS symptoms, patients recorded specific symptoms on an 11-point scale for a total score of 60 points.

During the nVNS treatment, total VS symptoms scale score decreased from 40 to 37 points in patient 1, 40 to 20 points in patient 2, and 41 to 27 points in patient 3.​

Since visual snow syndrome is often associated with tinnitus, this could be useful.

 

This guy truly deserves an award.


Michael Kilgard
Published in July 10, 2018

 

Award for what?

 

You can come up with a catchy name for it yourself. But I bet no-one on this forum will ever believe anything he ever says again.

He wasn't lying to us, though, when saying it was in "late stages of development".

 

Hello,

Would stimulation of the vagus nerve help reduce the intensity of somatosensory tinnitus originating from the neck, such as the digastric and sternocleidomastoid muscles?

Why was vagus nerve stimulation not developed more after this study?

Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series

 

@Josh59, I believe that the main reasoning behind the cancelation of this research was the surgery involved. Insurance companies do not want to pay for this procedure due to tinnitus being something that they do not deem life threatening.

Dr. Shore's device builds off of this research (which, bear in mind, was proven to work!) except her device, unlike the vagus nerve stimulation implant, is minimally invasive for the patient and therefore a cheaper alternative.

 

See Dr. Kilgard's statement above, then ask yourself, how does this compute?

^^^ I mean, I don't get it. Why is it it that people pick up a topic and then, without establishing it in context with the background, without providing any sources, they present it as an overarching theory of everything, and when someone calls it into question, they won't bother?

 

Sorry for resurrecting an old thread, but:

There's a (former) anesthesiologist in the Netherlands who offers pulsed radiofrequency treatment of the auricular branch of the vagal nerve.

Over the years, he and his son have published several research papers on tinnitus, including this paper.

In the past, I've been to his clinic for chronic nerve pain – which greatly helped me at the time.

Could anyone weigh in on whether this treatment would be worth a shot?

I've done some research on vagus nerve treatment via the forums. Initially, the treatment appeared somewhat promising – but ultimately discussion died down.

I'll call the clinic next week to ask if they can send over more information.

 

Nothing exciting. Animal study using VNS with and without audio versus placebo after salicylic induced tinnitus.

Effectiveness of transcutaneous vagus nerve stimulation (tVNS) on salicylate-induced tinnitus

 

This type of study has been carried out frequently for some time now.

I hope that serious protocols (like Dr. Shore's) will be put in their place and published. The aim being to reduce hyperactivity in the cochlear nuclei, brain stem, etc.

 

Yet another study on Vagus Nerve Stimulation. No improvement in humans.

→ Effectiveness of transcutaneous vagus nerve stimulation for the treatment of tinnitus: an interventional prospective controlled study

 

I'm astonished Michael Kilgard's job at the university goes unchallenged, given the extent of his scientifically unsound claims, that is, lies.