Vagal Nerve Stimulation for Gastroparesis

(ABVN2 Trial)

Overseen By

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pregnancy, Prisoners, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stimulating a nerve near the ear can manage symptoms like nausea and vomiting in individuals with stomach issues, specifically gastroparesis. Gastroparesis slows or stops food from moving from the stomach to the intestines. The treatment, Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS), uses a gentle electrical pulse on the ear to influence the vagus nerve, which helps control stomach functions. The study includes two groups: one with individuals who have gastroparesis and another with healthy individuals without stomach problems. Those with a confirmed diagnosis of gastroparesis or who frequently experience related symptoms might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that this technique is safe for stimulating the vagus nerve?

Research has shown that transcutaneous auricular vagal nerve stimulation (TaVNS) is generally safe. TaVNS uses gentle electrical pulses on the ear, and studies have found it can safely influence stomach function. For instance, one study found that using TaVNS for four hours in healthy individuals altered stomach movement without causing serious side effects.

Another study found that TaVNS improved certain stomach rhythms in healthy individuals exposed to cold, suggesting it might help with issues like nausea and vomiting. Overall, research supports the safety of TaVNS, with no major negative effects reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) for gastroparesis because it offers a non-invasive approach to managing the condition. Unlike traditional treatments that often involve medications to stimulate stomach muscles or manage symptoms, TaVNS works by using electrical stimulation to influence the vagus nerve, which plays a key role in gastrointestinal function. This method has the potential to reduce symptoms without the side effects associated with medications, offering a novel mechanism of action that could improve quality of life for patients with gastroparesis.

What evidence suggests that Transcutaneous Auricular Vagal Nerve Stimulation might be an effective treatment for gastroparesis?

Research has shown that Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) can improve stomach function. This trial will include two groups: healthy subjects and those with gastroparesis. Studies have found that TaVNS aids in moving food through the stomach more effectively, enhancing gastric motility. In healthy individuals, this treatment boosts vagal activity, which is crucial for good digestion. One study discovered that TaVNS can enhance gastric slow waves, which help coordinate stomach movements. Overall, early findings suggest that TaVNS positively affects stomach function and could assist with conditions like gastroparesis, where the stomach doesn't empty properly. ^{2 3 6 7 8}

Who Is on the Research Team?

Thomas Nowak, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals with gastroparesis, a condition that affects stomach emptying. It's open to those who haven't had a gastric stimulator placed and are interested in non-invasive nerve stimulation therapy.

Inclusion Criteria

I am healthy with no stomach issues unrelated to COVID-19.

I have been diagnosed with gastroparesis by a GI doctor.

I am willing to have electrodes placed on my ear.

Exclusion Criteria

I am unable to give my consent.

Pregnant females

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stimulation

Subjects undergo transcutaneous stimulation of the auricular branch of the vagus nerve and blood draws before and after stimulation

3 hours

1 visit (in-person)

Vagal Maneuvers

Subjects undergo vagal maneuvers using either regular EKG electrodes or MEA electrodes

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stimulation and maneuvers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS)

Trial Overview

The study tests the effects of ABVN (auricular branch of vagal nerve) stimulation on nerve action potentials and gastric hormones using devices like GES, TaVNS, PENFS, and a wrist-worn Cardio Watch.

How Is the Trial Designed?

Group I: Healthy Subjects Experimental Treatment 2 Interventions

Subjects who have no gastric symptoms or conditions

Group II: Gastroparesis Subjects Experimental Treatment 2 Interventions

Subjects with a confirmed diagnosis of gastroparesis.

Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) is already approved in European Union, United States for the following indications:

Approved in European Union as TaVNS for:

• Epilepsy
• Depression
• Pain
• Migraine

Approved in United States as TaVNS for:

• Epilepsy
• Depression
• Chronic pain syndromes
• Migraine

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) using specific parameters (500μs pulse width at 10Hz and 25Hz) was found to significantly decrease heart rate (HR) in healthy individuals, indicating its potential efficacy in modulating HR.

The study demonstrated that taVNS is safe, with no adverse effects reported, and it effectively attenuated sympathetic HR rebound after stimulation, suggesting a beneficial impact on autonomic regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. Badran, BW., Mithoefer, OJ., Summer, CE., et al.[2020]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.

The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. Wang, Y., Li, L., Li, S., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and well-tolerated method for treating conditions like drug-resistant epilepsy, but a recent randomized double-blind trial found no significant difference in outcomes between high- and low-stimulation groups.

The most common side effect of taVNS is a tingling sensation or pain at the stimulation site, and while it shows promise, further research is needed to fully understand its efficacy and to potentially gain approval for insurance coverage in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. Yamamoto, T.[2022]

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.

The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

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sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X2100125X

A randomized, double-blind trial in healthy individuals

We provide evidence that 4-h of taVNS influences gastric motility in healthy human participants for the first time using rtMRI.

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Noninvasive transcutaneous auricular vagal nerve stimulation improves gastric slow waves impaired by cold stress in healthy subjects. Neuromodulation 2023 ...

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Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 ...

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academic.oup.com

academic.oup.com/gastro/article/doi/10.1093/gastro/goaf009/7979382

Efficacy of vagus nerve stimulation in gastrointestinal disorders

We performed a systematic review to determine the efficacy of invasive and non-invasive VNS in gastrointestinal disorders.

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pmc.ncbi.nlm.nih.gov/articles/PMC8192665/

Transcutaneous Auricular Vagus Nerve Stimulation

The purpose of taVNS is to treat a disease non-invasively by applying electrical current to the cutaneous receptive field formed by the auricular branch of the ...

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jamanetwork.com

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Transcutaneous Auricular Vagus Nerve Stimulation for ...

Main Outcomes and Measures The primary outcome was the incidence of moderate to severe postpartum uterine contraction pain on the third ...

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frontiersin.org

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International Consensus Based Review and ...

Currently, auricular acupuncture, which can mimic transcutaneous vagus nerve stimulation (tVNS), is reported in numerous systematic reviews to be effective ...