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Vagus Nerve Stimulation And Inflammation

Non-Invasive Vagus Nerve Stimulation Conceptual Representation
Non-Invasive Vagus Nerve Stimulation Conceptual Representation

Vagus Nerve Stimulation

Vagus nerve stimulation (VNS) is a medical treatment that is routinely used in the treatment of epilepsy and other neurological conditions. VNS studies are not just clinically, but also scientifically informative regarding the role of the vagus nerve in health and disease.

Vagus Nerve Stimulation Device and Method

Non-Invasive Vagus Nerve Stimulator Attached to the Auricular Concha via Ear Clip
Non-Invasive Vagus Nerve Stimulator Attached to the Auricular Concha via Ear Clip

Vagus nerve stimulation works by applying electrical impulses to the vagus nerve. The stimulation of the vagus nerve can be performed in two different ways: a direct invasive stimulation, which is currently the most frequent application and an indirect transcutaneous non-invasive stimulation. Invasive VNS (iVNS) requires the surgical implantation of a small pulse generator subcutaneously in the left thoracic region. In contrast to iVNS, transcutaneous VNS (tVNS) allows for a non-invasive stimulation of the vagus nerve without any surgical procedure. Here, the stimulator is usually attached to the auricular concha via ear clips and delivers electrical impulses at the subcutaneous course of the afferent auricular branch of the vagus nerve (2).

A pilot study that examined the application of VNS in 60 patients with treatment-resistant depressive disorder showed a significant clinical improvement in 30–37% of patients and a high tolerability (3). Five years later, the stimulation of the vagus nerve for the treatment of refractory depression was approved by the U.S. Food and Drug Administration (FDA) (4). Since then, the safety and efficacy of VNS in depression has been demonstrated in numerous observational studies as can be seen below. In contrast, there is no randomized, placebo-control clinical trial that reliably demonstrates antidepressant effects of VNS.

The vagus nerve represents the main component of the parasympathetic nervous system, which oversees a vast array of crucial bodily functions, including control of mood, immune response, digestion, and heart rate. It establishes one of the connections between the brain and the gastrointestinal tract and sends information about the state of the inner organs to the brain via afferent fibers. In this review article, we discuss various functions of the vagus nerve which make it an attractive target in treating psychiatric and gastrointestinal disorders. There is preliminary evidence that vagus nerve stimulation is a promising add-on treatment for treatment-refractory depression, posttraumatic stress disorder, and inflammatory bowel disease. Treatments that target the vagus nerve increase the vagal tone and inhibit cytokine production. Both are important mechanism of resiliency. The stimulation of vagal afferent fibers in the gut influences monoaminergic brain systems in the brain stem that play crucial roles in major psychiatric conditions, such as mood and anxiety disorders. In line, there is preliminary evidence for gut bacteria to have beneficial effect on mood and anxiety, partly by affecting the activity of the vagus nerve. Since, the vagal tone is correlated with capacity to regulate stress responses and can be influenced by breathing, its increase through meditation and yoga likely contribute to resilience and the mitigation of mood and anxiety symptoms.

VNS In Inflammatory Bowel Disease (IBD)

Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin (5) and intestinal inflammation (6). The VNs also indirectly modulates immune activity of the spleen through connections with the splenic sympathetic nerve (7). In rats with colonic inflammation, the 3-hour long daily VNS for a period of 5 days led to a reduction in inflammatory markers and an improvement in symptoms of colitis (8).

Vagus nerve stimulation should be of interest in other inflammatory diseases, such as rheumatoid arthritis, another TNF-α-mediated disease. In patients with rheumatoid arthritis, a study that demonstrated an improvement of symptoms in the early and late stages of the disease through 1–4 minutes of VNS daily (9). This study was also the first to show that VNS inhibits the production of TNF-α (also known as TNF-alpha) and other cytokines in humans by stimulating the inflammatory reflex, leading to an improvement of symptom severity. These data argue for an anti-inflammatory role of the vagus nerve and provide potential therapeutic applications for patients with IBDs (10, 8, 11).

Conclusion

The interaction between the gut and the brain is based on a complex system that includes not only neural but also endocrine, immune, and humoral links.

The vagus nerve is an essential part of the brain–gut axis and plays an important role in the modulation of inflammation, the maintenance of intestinal homeostasis, and the regulation of food intake, satiety, and energy homeostasis. An interaction between nutrition and the vagus nerve is well known, and vagal tone can influence food intake and weight gain.

Moreover, the vagus nerve plays an important role in the pathogenesis of psychiatric disorders, obesity as well as other stress-induced and inflammatory diseases.

Vagus nerve stimulation and several meditation techniques demonstrate that modulating the vagus nerve has a therapeutic effect, mainly due to its relaxing and anti-inflammatory properties.

Extinction paired with VNS is more rapid than extinction paired with sham stimulation. As it is currently approved by the Federal FDA for depression and seizure prevention, VNS is a readily available and promising adjunct to exposure therapy for the treatment of severe anxiety disorders.

Vagus nerve stimulation is an effective anticonvulsant device and has shown in observational studies antidepressant effects in chronic treatment-resistant depression. Because the vagus nerve sends information to brain regions is important in the stress response (LC, orbitofrontal cortex, insula, hippocampus, and amygdala), this pathway might be involved in perceiving or manifesting various somatic and cognitive symptoms that characterize stress-related disorders.

Psychotropic drugs, such as serotonin reuptake inhibitors, have effects on both the brain and the gastrointestinal tract and consequently should be understood as modulators of the brain–gut axis.

Research investigating the interaction between nutritive factors, somatic factors, such as heart rate, psychological and pharmacological treatments, and vagal activity has the potential to lead to integrative treatment options that incorporate VNS, nutritional approaches, drugs, and psychological interventions, such as mindfulness-based approaches, which can be tailored to the needs of the individual patient.

A Final Thought About Vagus Nerve Stimulation And CES

Cranial Electrotherapy Stimulation (CES) has been engaging Vagus nerve stimulation for decades, through the use of ear clips to stimulate the nerve endings in the ears. Recent data from clinical studies and practical application reflect the positive results that may be gained by applying low amplitude, extremely low frequency (ELF) electric currents, through the Vagus nerve system. The CES Ultra cranial electrotherapy stimulator device incorporates both ELF and ear clip attachments, as part of its standard application to treat anxiety, depression, and insomnia without medication.

Get Your Own CES Ultra for only $249

Citations

  1. Frontiers in Psychiatry – Vagus Nerve as Modulator of the Brain–Gut Axis in Psychiatric and Inflammatory Disorders (original publication)
  2. National Center for Biotechnology Information, U.S. National Library of Medicine – Effect of transcutaneous auricular vagus nerve stimulation on major depressive disorder: A nonrandomized controlled pilot study
  3. Springer Nature – Vagus Nerve Stimulation (VNS™) for Treatment-Resistant Depression: Efficacy, Side Effects, and Predictors of Outcome
  4. ScienceDirect® – Safety and efficacy of Vagus Nerve Stimulation in treatment-resistant depression. A systematic review
  5. Springer Nature – Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin
  6. Springer Nature – Stimulation of the vagus nerve attenuates macrophage activation by activating the Jak2-STAT3 signaling pathway
  7. American Association for the Advancement of Science – Acetylcholine-Synthesizing T Cells Relay Neural Signals in a Vagus Nerve Circuit
  8. ScienceDirect – Anti-inflammatory effect of vagus nerve stimulation in a rat model of inflammatory bowel disease
  9. PNAS – Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis
  10. The Physiological Society – Anti‐inflammatory properties of the vagus nerve: potential therapeutic implications of vagus nerve stimulation
  11. Clinical Medicine Insights: Gastroenterology – Bioelectrical Stimulation for the Reduction of Inflammation in Inflammatory Bowel Disease
  12. CES Ultra – The Role of CES in Fighting Inflammation
  13. CES Ultra – Non-Drug Relief From Anxiety.

Last Modified: September 10, 2019

Happy Thanksgiving: What I’m Thankful For

Thanksgiving is here, so our minds have turned
To what time has taught us, to what we’ve learned:
We often focus all our thought
On shiny things we’ve shopped and bought.
We take our pleasure in material things,
Forgetting the pleasure that friendship brings.
If a lot of our stuff just vanished today,
We’d see the foundation of each happy day
Is special relationships, constant and true,
And that’s when our thoughts go directly to you.

We wish you a Thanksgiving you’ll never forget,
Full of love and joy—your best one yet!

Kids on Drugs ( Thanks to Parents and Doctors) – part 2

Part 2: How CES, the Drug Free Alternative, Can Make a Difference

Part 1

One Parent’s Experience

CES Ultra Improves Sleep, Reduces Anxiety, Irritability, and Depression in 14-year-old Male

We’ve been doing a trial with the CES Ultra the past week. The subject was DS*, our 14 year old with diagnosed insomnia, anxiety, and depression. He used the unit for 20 minutes per day, at bedtime.

I would rate the improvement in apparent anxiety and depression to be significant. Anxieties are no longer a major topic of discussion. DS is starting to leave the house on his own for activities other than school. He’s walked outside for exercise many days since starting the program. Last night he performed with his school orchestra and said he didn’t feel strung out about it like he usually has in the past. He settled down well afterwards, which is a first.

Insomnia has shown moderate improvement. We had hoped for more improvement in that department, but perhaps we will see this continue over a longer term. DS does like to use it at bedtime, finds it easier to fall asleep. He is no longer asking for a prescription for sleeping pills. But still some early-morning wakening, etc.

My DH and I find our son more talkative, less defensive, and quite a bit more mellow in the past week. That is something we have not seen for a long time. Irritability has been markedly decreased … now closer to normal teenage irritability than what we endured before. I suspect the reduced anxiety and reduced depression are contributing to the mellower kid.

Side effects: DS feels dozy after using it. Would not do a treatment just before driver’s ed. No negative side effects otherwise noted.

Our family gives CES an “A” grade and a “thumbs up.” The unit’s positive effect on our anxious, depressed, irritable, insomniac teen has taken a lot of stress off of the entire family. And I must add, finding a psych doc who gave us a free (with consult) week-long trial period on the device was very helpful before making the full investment in purchase, which we plan to do.

* (For the sake of privacy, identities are withheld.)

Brief Research Study

Smith, Ray B., McCusker, Charles F., Jones, Ruth G., and Goates, Delbert T.  The use of cranial electrotherapy stimulation in the treatment of stress related attention deficit disorder, with an eighteen month follow up. Unpublished, 1991 and follow-up in 1993.

This study compared the effects of 3 randomly assigned CES devices which had marked differences in electrical stimulation parameters, in the treatment of stress related attention deficit disorder in 23 children and adults, 9 males, 14 females, 9 – 56 years old (average 30.96) with an average education level of 10.56 years. All had been diagnosed as having generalized anxiety disorder (61%), and/or depression (45%), and/or dysthymia (17%). 8 had a primary diagnosis of ADD. CES treatments were given daily, 45 minutes per day for 3 weeks. All 3 CES devices were equally effective based on Duncan’s Range test in significantly (P<.001) reducing depression as measured on the IPAT depression scale (mean of 19.38 ± 8.44 pretest to 13.19 ± 7.00 post test), state and trait anxiety scales of the STAI (mean state anxiety was reduced from 39.95 ± 11.78 pretest to 29.76 ± 6.99 post test, and the mean trait anxiety was reduced from 43.90 ± 11.31 pretest to 32.19 ± 7.50 post test), and in increasing the Verbal pretest (mean of 99.38 ± 13.20 to post test of 107.50 ± 14.13), Performance (mean of 107.4 ± 15.05 to 126.6 ± 14.2 ), and Full Scale I.Q. scores on the WISC-R or WAIS-R IQ tests (mean of 103.2 ± 13.7 to 117.6 ± 14.28). The authors concluded that in the unlikely event that our findings are the results of placebo effect alone, a CES device, retailing at approximately $795, would still be a relatively inexpensive and apparently reliable treatment for such a debilitating disorder as stress related ADD. On 18 month follow up, the pts performed as well or better than in the original study, the Full Scale IQ had not moved significantly from where it was after the first 3 weeks of treatment, the Performance IQ fell back slightly, while the Verbal IQ continued to increase. There did not seem to be any pattern of addiction to or over dependence on the CES device. There was no side effects except for 1 pt who cried during treatments, and 1 who was sore behind the ears when the electrode gel began drying out.

The cornerstone tenet of medicine is “Do no harm.” Don’t you owe it to your child to try a safe, effective, non-invasive approach before turning to drugs? Consider the CES Ultra.

Another Therapist Reports: CES Intervention Diffuses Anger, Decreases Hyper-Irritability, & Improves Health of 21-year-old Female College Student after Other Therapies Fail.

Operation Pro-Vet

The Problem

Tens of thousands of Iraqi and Afghan veterans have returned home from the wars with a debilitating condition: post-traumatic stress disorder (PTSD. The VA is at loose ends about how to deal with a mental health crisis that is ruining not only the lives of returning vets, but those of their families and friends as well. Drug therapy, which is the main way they have treated the problem, has proven to be not only ineffective, but has worsened the situation, triggering an extraordinary spike in substance abuse, leading to violent behaviors and suicide.

cranial-stimulation-prevent-suicide

Read Brig. General (Ret) Stephen Xenakis MD, on the plight of our veterans at Huffingtonpost

Watch General Xenakis on Fox News, discussing how CES can help treat PTSD at FoxNews

An Answer?

Fortunately, there is a nondrug option with a proven track record in treating anxiety, depression, and insomnia which are the primary symptoms of PTSD. It’s called cranial electrotherapy stimulation, or CES. It’s an electronic device that is simple to use, has no side effects, and has been validated by decades of research. CES is currently being prescribed for active duty personnel returning from the mid-east at the Warrior Combat Stress Reset Program at Ft. Hood, TX, at Ft. Campbell, KY, Ft. Joint Ft Lewis-McChord, WA, at the Bremerton WA Naval Hospital, as well as in combat conditions in Iraq and Afghanistan. It should not stop there.

Operation Pro-Vet: How You Can Help

CES units generally retail for $350-$995. Because they are not generally covered by health insurance, they are most often out of the reach of veterans most of whom have a limited income or who are currently unemployed. Neuro-Fitness LLC, the manufacturer of the CES Ultra—in recognition of those who have given so much for their country—will now make available its CES unit at wholesale cost to veterans, not only of our current wars but our past wars as well as to their families. We are also working with Service clubs to make available units at a special low cost so that they may then be distributed to veterans in need.

To learn more about CES, visit us at our website: www.cesultra.com. To learn more about the program, call us at 1-425-222-0830 or email us today at sales@ cesultra.com for more information and how your local group or organization can become part of this program to assist those who have served on our behalf. They deserve nothing less.

A View from the Trenches: Why Psychiatry needs CES – Part 1

Why Psychiatry needs CES
by Jason Worchel, M.D.

Jason Worchel, M.D. is a noted psychiatrist and Director of the Hilo Mental Health Center in Hilo, HI. The following posts are taken from a paper written by Dr. Worchel in his testimony before the F.D.A. concerning the effectiveness and safety of CES from the perspective of a practicing psychiatrist.

The Challenge of Psycho-Pharmacology

As a practicing psychiatrist, I am constantly struggling with balancing purported efficacy with known risks of somatic interventions. While currently approved interventions have demonstrated efficacy relative to placebo, the rate of improvement with placebo remains consistently above 30%.

With the increasing prevalence of polypharmacy, there is an increasing risk of adverse side effects for the statistical hope for improved outcomes as demonstrated in clinical trials conducted with select populations in controlled environments. In addition to evaluating the risk/benefits of various treatments, I know from multiple studies most patients are not adherent to the prescribed medication regimens and discontinue medications altogether within a relatively short period of time.

Though my goal is to treat the presenting illness or alleviate its symptoms, my primary duty to my patients is to “do no harm.” This typically results in an approach that follows a spectrum of interventions with initial treatments being those with the least risk of adverse side effects.

There is no risk conventional interventions that currently constitute the standard of care will be bypassed by using CES.

Experience

I have worked with primary care physicians in our federally qualified health clinics on the Big Island. They, like others across the country, are stymied and frustrated by the challenge of treating chronic pain.

In particular, they face patients with bona fide pain but who also have depression, anxiety, insomnia and substance abuse. With regards to treatment interventions, they are damned if the do and damned if the don’t treatment with various classes of analgesic medications, including narcotic medications.

They are particularly afraid of the increasing fatalities occurring with the use of narcotic analgesic medications in combination with benzodiazepines and antidepressant medications. They welcome alternatives to medications for those patients whose emotional distress intensifies their suffering and pain sensation. CES could provide a safe alternative for them that do not currently exist.

In summary, CES represents as safe intervention for conditions for which existing treatments, especially pharmacologic and invasive interventions pose significant risk for adverse side effects. It is especially beneficial in defined populations. These include those who refuse medications and psychotherapy, dual diagnosed patients, geriatric patients, females of child bearing age and during pregnancy.

Advantages of CES

I would like to highlight various advantages of CES relative to other existing treatments, especially medications that may not be well appreciated. Take for example, the difficulty faced by primary care physicians and mental health professionals in treating female patients of child bearing age. All available medications have teratogenic risk and are not recommended during pregnancy and breast feeding. Patients desiring to become pregnant have justified concerns about taking psychotropic medication

cesultra, ces ultra, cranial electrotherapy How To

Current treatment algorithms encourage polypharmacy when initial treatments with a single drug are not effective. While there is some increased response, polypharmacy only increases the side effects burden and can result in untoward drug/drug interactions. These types of problems do not occur with CES.

Many psychotropic medications for the treatments of depression, anxiety and insomnia have discontinuation syndromes. Given the high rate of discontinuation of these medications by patients due to side effects and lack of efficacy, many patients unfortunately suffer when the take a medication prescribed to alleviate their suffering. This does not occur with CES. There are circumstances, for example prior to surgery, when certain psychotropic medications are required to be discontinued. CES does not have to be discontinued prior to surgery.

One my greatest concerns in treating patients with depression, anxiety and insomnia involves suicide. We know increased risk of suicide in depressed patients but it is often global insomnia is a significant risk factor for suicide as well as anxiety/agitation. Although safer than the older tricyclic and tetracylcic antidepressants, the current medications carry a significant risk of death in overdose, especially when combined with other analgesic medications. Too often, the medications we prescribed to prevent suicide become a means through which the patient attempts suicide. In fact, there are black box warnings that these medications may increase suicidal impulses, especially in adolescents. CES does not pose this risk.

As in many developed countries, we are an aging population. The treatment of depression, anxiety and insomnia in the geriatric patients with medications present unique challenges due to the increased risk of adverse side effects. These side effects include the risk of falls and motor vehicle accidents. Again, the number of medications taken in our geriatric patients continues to increase. Thus risk of adding psychotropic medications to their other medications poses additional drug/drug interactions and side effect burden.

CES avoids this disadvantage and provides a safe alternative to patients, their families and care givers. Furthermore, missing a CES treatment does not carry the risks of missing doses of psychotropic medications in this population.

CES Ultra research – read more – http://www.cesultra.com/research-resources.htm