Vagal Nerve Stimulation for Reducing Nasogastric Tube Use

Overseen By Carly Riedmann, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jacques E. Chelly

Disqualifiers: Pregnancy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Vagal Nerve Stimulation for reducing nasogastric tube use?

Research shows that non-invasive vagus nerve stimulation (nVNS) with devices like gammaCore can help with conditions like migraines and headaches by modulating pain and inflammation. This suggests that nVNS might also have potential benefits for other conditions, such as reducing the need for nasogastric tubes, by influencing similar pathways in the body. ^{1 2 3 4 5}

Is non-invasive vagus nerve stimulation (nVNS) safe for humans?

Non-invasive vagus nerve stimulation (nVNS), including devices like gammaCore, has been used safely in humans for conditions like migraines and headaches. Studies show it has an excellent safety profile, with few side effects, making it a well-tolerated treatment option. ^{1 2 3 4 6}

How is the vagal nerve stimulation treatment different from other treatments for reducing nasogastric tube use?

This treatment uses a non-invasive device to stimulate the vagus nerve, which is unique because it doesn't require surgery and is portable, making it more convenient and safer compared to traditional implanted devices. It has been used for other conditions like migraines and headaches, showing its potential to modulate pain and inflammation without the side effects of medications. ^{1 2 3 4 7}

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.

Research Team

Jacques E Chelly, MD, PhD, MBA

Principal Investigator

University of Pittsburgh, UPMC

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

Pregnant subjects

I cannot give consent due to a developmental or neurological condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham vagal nerve stimulation post-operatively until the NG tube is removed

Up to 30 days

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo Vagal Nerve Stimulator
• Vagal Nerve Stimulator

Trial Overview 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.

Participant Groups

Group I: Vagal Nerve Stimulator Group Experimental Treatment 1 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 Group Placebo Group 1 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

Who Is Running the Clinical Trial?

Jacques E. Chelly

Lead Sponsor

Trials

10

Recruited

710+

Findings from Research

The study involving 20 healthy participants demonstrated that transcutaneous noninvasive vagus nerve stimulation (nVNS) significantly reduced levels of inflammatory cytokines like IL-1β and TNF, indicating its potential as an anti-inflammatory treatment.

In contrast, the sham stimulation group showed an increase in IL-8 levels, highlighting the effectiveness of nVNS in modulating the immune response compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial. Lerman, I., Hauger, R., Sorkin, L., et al.[2022]

The gammaCore device, a non-invasive vagus nerve stimulation (nVNS) system, has been FDA-cleared for the acute treatment of pain in patients with episodic cluster headaches, showing its efficacy in managing primary headache disorders.

Clinical studies indicate that nVNS effectively stimulates the same vagus nerve fibers as the traditional implanted vagus nerve stimulation (iVNS), suggesting a similar mechanism of action for headache relief without the associated risks of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of action of non-invasive cervical vagus nerve stimulation for the treatment of primary headaches. Simon, B., Blake, J.[2018]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Noninvasive vagus nerve stimulation (nVNS) using the GammaCore® device is effective for aborting migraine attacks, but its effect size is modest and not superior to other noninvasive methods or oral triptans.

nVNS has an excellent safety and tolerance profile, making it a favorable option for migraine treatment, although its preventive effects are not significantly better than sham stimulation, except possibly in patients who consistently adhere to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation. Schoenen, J., Ambrosini, A.[2021]

In a small study of six very young children (average age 20.5 months) who underwent vagus nerve stimulation (VNS) for epilepsy, 83% experienced a significant reduction in seizure frequency, with 33% becoming seizure-free.

No adverse effects or complications were reported from the VNS procedure, suggesting it is a safe option for treating life-threatening epilepsy in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation in children less than 5 years old. Blount, JP., Tubbs, RS., Kankirawatana, P., et al.[2018]

In a study involving 248 participants with episodic migraine, noninvasive vagus nerve stimulation (nVNS) was found to be significantly more effective than a sham treatment for achieving pain freedom at 30 and 60 minutes after treatment.

nVNS was safe, well-tolerated, and provided effective pain relief, demonstrating a 13.2% absolute increase in the likelihood of being pain-free 2 hours post-treatment, making it a practical option for acute migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Tassorelli, C., Grazzi, L., de Tommaso, M., et al.[2022]

In a study involving 28 healthy participants, noninvasive vagal nerve stimulation (nVNS) significantly reduced lacrimation compared to no stimulation and one type of sham stimulation, indicating its potential efficacy in modulating autonomic responses.

However, the study found that the sham device also produced similar effects, suggesting that both nVNS and the sham device can influence the trigeminal-autonomic reflex, which may explain the high placebo effects seen in previous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

nVNS sham significantly affects the trigeminal-autonomic reflex: A randomized controlled study. Schroeder, CF., Möller, M., May, A.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanism of action of non-invasive cervical vagus nerve stimulation for the treatment of primary headaches. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation in children less than 5 years old. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

nVNS sham significantly affects the trigeminal-autonomic reflex: A randomized controlled study. [2020]