Vagal Nerve Stimulation for Reducing Nasogastric Tube Use
Palo Alto (17 mi)Overseen byJacques E Chelly, MD, PhD, MBA
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Jacques E. Chelly
No Placebo Group
Trial Summary
What is the purpose of this trial?Abdominal surgery, laparoscopic or open, is frequently performed at UPMC Shadyside hospital. One of the most frequent complications following abdominal surgery is a postoperative ileus. Although postoperative ileus may be the result of obstruction or leakage, in most cases postoperative ileus (POI) is the result of local irritation because of fluid overload, exogenous opioids, neurohormonal dysfunction, gastrointestinal stretch, local bleeding and inflammation. POI usually lasts between 2 to 7 days. In most cases, a nasogastric tube (NG tube) is used to relieve that gastric pressure until the resolution of the POI. The placement of a NG tube can lead to a local trauma, bleeding and pain. Pain represents a major complaint among those with POI, often contributing to prolonged hospital stays.
Is the treatment Placebo Vagal Nerve Stimulator, Vagal Nerve Stimulator a promising treatment for reducing nasogastric tube use?The Vagal Nerve Stimulator, known as gammaCore, is a promising treatment because it is non-invasive, meaning it doesn't require surgery, and is portable and safe. It has been used to treat headaches and migraines effectively, and it may help with pain and inflammation. This makes it a hopeful option for reducing the need for nasogastric tubes.23567
What safety data exists for vagus nerve stimulation treatments?The safety profile of non-invasive vagus nerve stimulation (nVNS), including devices like gammaCore, is generally favorable. Studies have shown that nVNS is well-tolerated with an outstanding safety profile, similar to other non-invasive neurostimulation techniques. It has been used for treating conditions like migraines and headaches, with the FDA clearing gammaCore for acute treatment of pain in episodic cluster headache patients. The non-invasive nature of nVNS, such as transcutaneous auricular vagus nerve stimulation (taVNS), offers a safe, inexpensive, and portable alternative to surgically implanted systems.23457
What data supports the idea that Vagal Nerve Stimulation for Reducing Nasogastric Tube Use is an effective treatment?The available research shows that Vagal Nerve Stimulation (VNS) has been used effectively for other conditions, such as headaches and migraines. For example, the gammaCore device, a non-invasive VNS, has been used to treat primary headaches and migraines, showing effectiveness in reducing pain. However, the effect size is modest compared to other treatments like oral medications. While VNS is known for its safety and minimal side effects, there is no specific data provided here about its effectiveness in reducing nasogastric tube use.12357
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for individuals who have had abdominal surgery at UPMC Shadyside and are experiencing a common complication called postoperative ileus (POI), which causes digestive slowdown. Participants must be in need of nasogastric tube relief due to POI but should not have conditions like obstruction or leakage causing the ileus.Inclusion Criteria
I am an adult scheduled for major abdominal surgery at UPMC Shadyside.
I have experienced a temporary stoppage of my bowel movements after surgery.
I expect to have a nasogastric (ng) tube placed.
Exclusion Criteria
I cannot read, write, or speak English fluently.
I cannot give consent due to a developmental or neurological condition.
Treatment Details
The study is testing whether a Vagal Nerve Stimulator can reduce the need for nasogastric tubes in patients with POI after abdominal surgery. Some participants will receive the actual device, while others will get a placebo version, to compare outcomes.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vagal Nerve Stimulator GroupExperimental Treatment1 Intervention
This arm of the study will be randomly assigned to receive the active vagal nerve stimulator device which is placed via electrodes on each side of the neck. The active device will experience two 45-minute sessions daily of vagal nerve stimulation until their Nasogastric (NG) tube is removed.
Group II: Placebo Vagal Nerve Stimulator GroupPlacebo Group1 Intervention
This arm of the study will be randomly assigned to receive a sham device that mirrors that of the active vagal nerve stimulator devices. The sham device arm will experience two 45-minute sessions daily of placebo vagal nerve stimulation until their Nasogastric (NG) tube is removed.
Placebo Vagal Nerve Stimulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as gammaCore for:
- Acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow
🇪🇺 Approved in European Union as gammaCore for:
- Migraine
- Cluster headache
Find a clinic near you
Research locations nearbySelect from list below to view details:
UPMC Shadyside HospitalPittsburgh, PA
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Who is running the clinical trial?
Jacques E. ChellyLead Sponsor
References
Vagus nerve stimulation in children less than 5 years old. [2018]Vagus nerve stimulation (VNS) has been used in both adults and older children with varying success.
Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial. [2022]The purpose of this study was to test the transcutaneous noninvasive vagus nerve stimulator (nVNS) (gammaCore©) device to determine if it modulates the peripheral immune system, as has been previously published for implanted vagus nerve stimulators.
Mechanism of action of non-invasive cervical vagus nerve stimulation for the treatment of primary headaches. [2018]Stimulation of the cervical vagus nerve with implanted vagus nerve stimulation (iVNS) has been used clinically for more than 20 years to treat patients with epilepsy. More recently, a non-invasive cervical vagus nerve stimulation (nVNS), gammaCore, was developed, which has been purported to also stimulate the vagus nerve without the cost and morbidity associated with an iVNS system. gammaCore has been used to acutely treat various types of primary headaches, including migraine and cluster headaches (CH), and for the prevention of episodic, chronic, and menstrual migraines and CH. The gammaCore device was cleared by the FDA for the acute treatment of pain in episodic CH patients. In this review, we summarize the clinical work that has been published in the use of gammaCore for treating primary headache disorders, present an overview of studies demonstrating that nVNS does indeed stimulate similar vagus nerve fibers as the implantable VNS system, and then present several animal headache-related studies that address the mechanism of action of nVNS.
Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. [2022]To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]Non-invasive vagus nerve stimulation (VNS) may be administered via a novel, emerging neuromodulatory technique known as transcutaneous auricular vagus nerve stimulation (taVNS). Unlike cervically-implanted VNS, taVNS is an inexpensive and non-surgical method used to modulate the vagus system. taVNS is appealing as it allows for rapid translation of basic VNS research and serves as a safe, inexpensive, and portable neurostimulation system for the future treatment of central and peripheral disease. The background and rationale for taVNS is described, along with electrical and parametric considerations, proper ear targeting and attachment of stimulation electrodes, individual dosing via determination of perception threshold (PT), and safe administration of taVNS.
nVNS sham significantly affects the trigeminal-autonomic reflex: A randomized controlled study. [2020]To determine whether high placebo effects observed in recently published clinical noninvasive vagal nerve stimulation (nVNS) trials can be attributed to an active modulation of the trigeminal-autonomic reflex by the sham device.
Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation. [2021]Noninvasive neurostimulation methods are particularly suited for migraine treatment thanks to their most favorable adverse event profile. Among them, noninvasive vagus nerve stimulation (nVNS) has raised great hope because of the role the vagus nerve is known to play in pain modulation, inflammation and brain excitability. We will critically review the clinical studies performed for migraine attack treatment and migraine prevention with the GammaCore® device, which allows cervical vagus nerve stimulation. nVNS is effective for the abortive treatment of migraine attacks, although the effect size is modest and numbers-to-treat appear not superior to those of other noninvasive neurostimulation methods, and inferior to those of oral triptans. The effect of nVNS with the GammaCore® in migraine prevention is not superior to sham stimulation, except possibly in patients with high adherence to the treatment. Both in acute and preventive trials, nVNS was characterized by an outstanding tolerance and safety profile, like the other noninvasive neurostimulation techniques. In physiological animal and human studies, cervical nVNS was shown to generate somatosensory evoked responses, to modulate pain perception and several areas of the cerebral pain network, and to inhibit experimental cortical spreading depression, which are relevant effects for migraine therapy.