Neurova - Targeting Neural, Hormonal and Immune Pathways
Neurova
The Neurova is a trans-cutaneous vagus nerve stimulation device with powerful and diverse therapeutic potential.
The Vagus Nerve: A Key Player
In order to appreciate the far reaching potential of vagus nerve stimulation (VNS) it is helpful to understand that the vagus nerve serves virtually every internal organ. It is the longest of the cranial nerves, linking the brain stem to the heart, lungs, gastrointestinal system, reproductive system, kidneys and other organs. It is the main conduit of the parasympathetic nervous system which along with the sympathetic controls involuntary functions such as heart rate, breathing, sweating, glucose balance and blood pressure and many other critical life functions.
FDA Approval of VNS Devices
It is no surprise therefore that any imbalance in the activity of the vagus nerve can have powerful and diverse effects on our health and this is certainly true. Stimulation of the vagus nerve (VNS) can redress these imbalances. One of the first approved applications of VNS was the control of drug resistant seizures.1-3 This is accomplished by surgically implanting an electrical device in the lower neck/upper chest area. These devices were approved for use in Europe in 1994 and subsequently approved by the FDA in 1997. Their use has resulted in a dramatic improvements in seizure control in many patients who were previously unresponsive to therapy.
Studies of large groups of patients with surgically implanted VNS devices for seizure control revealed many additional benefits. Firstly, there was a notable improvement in overall mood. In addition, significant weight loss and improvements in a number of metabolic indicators such as blood glucose levels were noted in a number of the subjects. Further research in these areas confirmed these initial observations and led to FDA approval of surgically implanted devices in drug resistant major depression (4-5) in 2005 and for weight loss (6-8) in 2015.
Non-Invasive VNS Options: (tVNS)
Naturally, surgically implanted devices are very expensive, require specialized surgical skills to deploy and although well tolerated, do have some associated risks. As such only a limited number of patients can benefit from these advancements and their application is limited to severe resistant conditions where their use can be justified.
More recently, it has been established that the vagus nerve can also be stimulated by external devices via its auricular (ear) branch (9,10) and at the neck (11). This method is referred to transcutaneous vagus nerve stimulation (tVNS). It has been confirmed with functional MRI studies that tVNS devices trigger increased activity in the areas of the brain which are known to receive the majority of the afferent vagus nerve fibers (signals from the internal organs to the brain): the nucleus tractus solitarius and locus coeruleus (9-11). The significance of this finding is that the powerful effects achieved with invasive measures can now be achieved with tVNS and accessed by a far greater number of patients, at lower costs and with far less risk.
Interestingly, practitioners in the field of auricular medicine have exploited these effects for many years, well before implanted VNS devices were introduced, but only with the advent of fMRI has their approach been validated. A number of tVNS devices have been cleared in Europe for epilepsy (12), depression (12), pain (12), headaches (13) and tinnitus (14,15). The FDA has recently approved tVNS devices for headaches (13) and opiate withdrawal (16). Studies on the effect of tVNS on weight loss, glucose, blood pressure control and many other applications have shown promising results. (17,18)
The Neurova recently received FDA approval after a study showed significant improvement in a group of men with advanced prostate cancer suffering from nights sweats secondary to androgen deprivation therapy (19). Furthermore, the study subjects demonstrated increases in heart rate variability during treatment - a specific response of increased vagal activity. The application of this device is functionally more sophisticated than alternative tVNS devices in that it employs a diagnostic component to determine the precise placement of the stimulator channels. It can therefore optimize the response to different medical conditions, compared to its predecessors.
The Vagus Nerve: Targeting Obesity and Metabolic Dysfunction
It may not be surprising that stimulating a cranial nerve can improve neurological symptoms such as seizures, pain or even depression. However, it may not be immediately apparent why this should result in weight loss, improved glucose control and other metabolic benefits (6). Studies have revealed a number of possible mechanisms responsible for these effects, including the well recognized “Gut Brain Axis” whereby signals are transmitted to and from the gastrointestinal system directly to the brain via the vagus nerve. Weight reduction resulting from vagus nerve stimulation may also be related to reduction in chronic, low grade inflammation which is known to be both a cause and result of obesity.
The Vagus Nerve: Targeting Inflammation and Auto-Immune Conditions
In 2002 a neurosurgeon by the name of Dr. Kevin Tracey published a landmark paper in which he demonstrated that stimulating the vagus nerve results in reduction of a ubiquitous inflammatory mediator known as TNF (20). The central role of TNF in inflammation has been demonstrated by the ability of agents that block the action of TNF to treat a range of inflammatory conditions, including rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease and psoriasis. In his fascinating 2015 article in Scientific American Tracey references a VNS study subject who had been almost bed bound due to pain and swelling related to rheumatoid arthritis. Within days of the receiving the implanted device his symptoms had improved and within weeks he was pain free! (21)
TNF and other inflammatory cytokines also play a role in the chronic low grade inflammation responsible for a number of metabolic and degenerative disorders. As one author puts it: “The process of inflammation has been shown to play a major role in most chronic illnesses, including neurodegenerative, cardiovascular, pulmonary, metabolic, autoimmune and neoplastic diseases” (22). The fact that VNS is able to reduce this inflammatory response may explain the diverse number of conditions improved by this treatment (23). For example, it has even been proposed that increased vagal activity may actually increase cancer survival regardless of cancer stage. This assertion is based on findings from colorectal and prostate cancer studies. (24,25)
The Vagus Nerve: Neurodevelopmental and Neurodegenerative Disorders
VNS is also emerging as a potential treatment for challenging neurodevelopmental disorders including autism (26) and neurodegenerative disorders including post traumatic stress disorder (PTSD), traumatic brain injury (TBI) and even Alzheimer’s disease (27,28). Pilot studies have actually shown very promising results.
The Vagus Nerve: Pain Management
In clinical practice tVNS devices are most commonly used to relieve chronic and recurring pain. FDA approval for this indication was granted on the basis of a growing body of literature supporting the use of VNS and tVNS in a number conditions associated with refractory pain: chronic pelvic pain, fibromyalgia, migraines and cluster headaches (29,30). Other common painful complaints often targeted with tVNS include back pain, sciatica, cervical pain, arthritic and other joint related pain, shingles and cancer related pain.
VNS Treatment at Luminnova Health
We hope to welcome Dr. Thomas Corbin (Phd.) to Luminnova Health in the near future. Dr. Corbin is one of the co-authors of the Neurova device study referenced above. He is very experienced in providing relief of chronic pain and other symptoms arising from musculoskeletal, neurological, cancer and auto-immune conditions. In addition to the Neurova, he utilizes a variety of modalities including advanced auricular medicine, therapeutic laser, laser acupuncture and SCENAR therapy.
Reference
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George, R & Salinsky, M & Kuzniecky, Ruben & Rosenfeld, W & Bergen, D & B. Tarver, W & Wernicke, Joe & International Vagus Nerve Stimulation Study Group, First. (2005). Vagus Nerve Stimulation for Treatment of Partial Seizures: 3. Long‐Term Follow‐Up on First 67 Patients Exiting a Controlled Study. Epilepsia. 35. 637 - 643. 10.1111/j.1528-1157.1994.tb02484.x.
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Rush AJ, George MS, Sackeim HA, Marangell LB, Husain MM, Giller C, Nahas Z, Haines S, Simpson RK Jr, Goodman R. Vagus nerve stimulation (VNS) for treatment-resistant depressions: a multicenter study. Biol Psychiatry. 2000 Feb 15;47(4):276-86.
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