tVNS Therapy — Electrocuting your ears!
Disclaimer:
I am not an MD or trained medical professional, but I am curious about new technologies that impact our quality of life. Today, mental health has finally become an essential branch under the well-being tree — something that should’ve always been.
For context: Stimulating your ears?
tVNS has promised a wide shot of remedies from the commonly known side-effects such as reduced inflammation, mood, and sleep improvement, and now cracking the surface of what it could and can do for those who have been ridden with severe depression, or as we’ll define it: chronic and treatment-resistant depression. A terrible place to be for someone fighting this uphill batter each day.
The entire premise of tVNS therapy takes advantage of a unique part of the human anatomy. Interestingly, this human body area has little skin resistance between the outer surface you can touch, while right underneath the surface sits your vagus nerve. The vagus nerve is the longest cranial nerve that links vital organs such as the brain, heart, abdomen, lungs, and more. tVNS is an electrical stimulation applied to the vagus nerve, commonly done non-invasively through the neck or ear.
The stimulation process is relatively straightforward, with two positive and negative leads make contact delivering a controlled, low voltage, and non-life-threatening current in a particular stimulation pattern. It is shown that vagus nerve stimulation is linked to reduced inflammation; however, overstimulation can result in fainting [1].
Research Today
Depression studies using tVNS treatment have become a popular topic; publications involving research studies in which subjects were given tVNS stimulation daily showed reduced scores on the HAMD (Hamilton Depression Rating Scale) after 4–6 weeks of treatment. People who have rheumatoid arthritis have demonstrated remission after a series of tVNS treatments. Other studies which focused on well-being improvement and changes in thinking also revealed promising results.
These studies from numerous academic institutions are still in progress, and the case for using tVNS in new medical conditions is building.
Nonetheless, the more serious the medical condition, the harder it is to prove a silver lining exists with one form of therapy. Often multiple combinations of different therapies assist efficacy — tVNS could be a novel, low-cost, and self-administered treatment available for large populations.
Depression and tVNS
As mentioned before, depression studies using tVNS treatment have risen in popularity in the previous years. The most cited studies include patients classified as majorly depressed undergoing tVNS treatment 30 mins/day for five days a week during a total four-week period.
In addition, all treatment was self-administered; patients had to complete journal entries for compliance reasons and notes during treatment. The results revealed a reduction in the severity of depression; however, there are inconsistencies between whether changes in the patient’s brains (post fMRI) lead to depression reduction.
Other studies found a decrease in depression symptoms post-treatment; however, they are also subject to the placebo effect or inconsistent administration (various studies allowed for self-administration).
A single cure for depression is hard.
Inflammation and tVNS
Research on rheumatoid arthritis (RA) inflammation suppression using VNS (stimulation applied to the neck region) has gained momentum. Research into whether tVNS can also benefit in providing treatment is still limited. Feinstein Institute for Medical Research and the Academic Medical Center at the University of Amsterdam has claimed RA inflammation is reduced after VNS treatment.
Other studies have proven VNS treatment to be beneficial in inflammation reduction, reducing sympathetic nerve activity. In terms of VNS treatment, GammaCore provides a pacemaker device that stimulates the neck region (more on this later).
Regulation, Regulation, Regulation
Anything that could alter the way you live your life will face regulation, some things not so much, and some suffering much-needed input — but we as humans are learning.
From a seemingly harmless Twinkie to life-saving treatments we now have available. Regulation is needed — however, maybe for a technology such as this, the FDA seems to have already realized the promises vagus nerve stimulation could bring.
“The Food and Drug Administration (FDA) has approved vagus nerve stimulation for people who:
1. Are four years old and older
2. Have focal (partial) epilepsy
3. Have seizures that aren’t well-controlled with medications
The FDA has also approved vagus nerve stimulation for the treatment of depression in adults who:
1. Have chronic, hard-to-treat depression (treatment-resistant depression)
2. Haven’t improved after trying four or more medications or electroconvulsive therapy (ECT), or both
3. Continue standard depression treatments along with vagus nerve stimulation
Additionally, researchers are studying vagus nerve stimulation as a potential treatment for a variety of conditions, including headaches, rheumatoid arthritis, inflammatory bowel disease, bipolar disorder, obesity, and Alzheimer’s disease.”
Source: Mayo Clinic [2]
The difference between what the FDA has approved today and what is being discussed is the same concept, stimulation of the vagus nerve. What differentiates them is the location.
Where could this go?
Well, this is where we can begin thinking, “what if?” — how does something such as this benefits humanity?
On the one hand, we have those who have it the worst — where a custom medical device could be administered to alleviate their suffering.
On the other hand, this technology is not ready to address chronic illnesses like depression and maybe still need 5+ years to collect data, validate, publish, peer-review, and then perhaps file for an IDE with the FDA to get the ball rolling.
For those wondering, an IDE is for clinical testing (Investigational Device Exemption) where a 510(k) clearance is not required. This is on the grounds of development and clinical testing.
What is a 510k clearance? A pass to begin marketing and commercial distribution of a device into the US market — you can now say your product has been FDA cleared. Of course, this path is long, and more notably, expensive. Costing as much as 500K and eating away anywhere from two to ten years of development.
The approval for a new medical device is long and. arduous, in return: rewarding. The follow-up question then becomes, where could this go today, or at least in the near term?
The Simulation Market
Today’s market is fragmented; it’s young, with no solid direction, and continuing down the research path. In summary, we understand it enough to make some money, but not ultimately to have it sell for the mass market. Like we said earlier, maybe this isn’t something for the mass market at all — or maybe it is?
tVNS and VNS devices fall into a category of TENS (transcutaneous electrical nerve stimulation) devices considered orthopedic devices by the FDA. Specific to tVNS/VNS treatment, the market currently hosts 3–4 dominant players selling treatment devices — a select few approved by the FDA, others gunning for their golden 510k ticket.
Holistically these devices are either too costly for consumer usage or require a prescription to purchase; some of these devices were used in the research studies that investigated the effects of tVNS treatment. Today, they stand outside the typical budgets of consumers; however, their medical background does help them garner enough pricing power to make this available for ~1–2K.
Each of these players has a device available today, the difference being how one can be acquired. NEMOS, sells a fantastic device, even seen in tVNS research papers as the system of choice.
Parasym, a younger company in the UK, has developed a lower cost and equivalently function device. They have been granted an IDE and are well on their way to pricing the functionality of their unit. Parasym conducted a clinical study using their device to uncover any indication of inflammation reduction or reducing heart rate variability (HRV). Their research proved successful in reducing the activity of the PNS system in study participants; activating the PNS system should reduce SNS activity (your fight or flight response).
“A controlled clinical study which measured the effect of the Parasym Device on the autonomic nervous system found that just 60 minutes of use had a significant increase in parasympathetic activity in the majority of participants.”
-Parasym
Summary
The technology is legitimate, the product is not entirely understood, and where it could go is TBD. Vagus nerve stimulation could be another tool for addressing the toughest to treat mental illnesses, or it may just be something to help the masses. Whether it reduces much-generated inflammation, helps us develop better sleep cycles, or really just calms our nerves in a 20–30 minute ear-piece session.
What seems to be one of the rate-limiting steps in specifically tVNS treatment becoming a better-suited therapy is its user interface: a compliant design, a low resistance process, and some method of feedback to prove effectiveness quantitatively.
- A market exists for tVNS treatment and is fragmented today.
- Research is still active in the field of VNS treatment; multiple topics from depression, inflammation to lifestyle and well-being are being investigated.
- However, large markets such as depression and migraines treatment are worth pursuing at the cost of navigating regulations to reach consumers.
- Companies such as Parasym are working toward a consumer product that can be purchased possibly without a prescription; others have proven technology readily transferable to future devices.
- tVNS technology is simple; cheaper TENS units can produce electrical signals that are required for tVNS, redesigning with a better UX focus can help highlight a new product
- Designing and testing an earpiece compliant to all ear sizes is paramount; multiple sizing options must be investigated.
For this reason, I think it may be interesting to explore what such a device could look like, function like and what it would mean. A follow-up to this article may be completed, where a design study into a mass-available tVNS device is thought through.
-Sukhraj Hothi
