taVNS for Irritable Bowel Syndrome

(IBS-taVNS Trial)

Overseen By Jie Chen, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioids, Antibiotics, Probiotics, others

Disqualifiers: Chronic pain, Diabetes, Psychiatric, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based treatment called transcutaneous auricular vagus nerve stimulation (taVNS) can safely and effectively help young adults manage pain and symptoms from irritable bowel syndrome (IBS). Participants will receive either the active treatment or a placebo version with reduced stimulation to determine if the real treatment makes a difference. The trial involves using the device at home twice daily for six weeks and tracking symptoms in a diary. It suits young adults with IBS who have experienced moderate pain for at least four days a week over the past three months and have internet access. As an unphased trial, this study offers an opportunity to explore innovative treatment options for IBS in a home setting.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have used probiotics or antibiotics within 2 weeks before enrolling.

What prior data suggests that this home-based taVNS intervention is safe for young adults with IBS?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe and well-tolerated. A review of multiple studies confirmed taVNS as a safe option for clinical use. In earlier studies, participants reported only mild side effects, such as skin irritation at the device site.

TaVNS sends small electrical pulses to the vagus nerve through the ear's skin. Research has explored this method for various conditions, indicating it as a practical and safe treatment approach. While some may experience tingling or discomfort, these effects are usually not serious.

Although this trial focuses on using taVNS at home, existing evidence supports its safety. This knowledge can help individuals feel more comfortable considering this treatment option in a trial setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for treating Irritable Bowel Syndrome because it offers a non-drug, non-invasive approach. Unlike standard treatments like dietary changes, fiber supplements, or medications that target symptoms, taVNS focuses on stimulating the vagus nerve via the ear, potentially addressing the root cause of IBS. This method could offer a new avenue for relief without the side effects often associated with medication. Plus, the convenience of a home-based treatment means greater accessibility and ease of use for patients.

What evidence suggests that home-based taVNS is effective for managing IBS-related pain and symptoms?

Studies have shown that transcutaneous auricular vagus nerve stimulation (taVNS) might help reduce symptoms of irritable bowel syndrome (IBS). Research suggests that taVNS can improve gut function by affecting the vagus nerve, which plays a role in digestion. In animal studies, taVNS increased bowel movements and helped food move through the gut, potentially relieving IBS symptoms. Additionally, taVNS reduced inflammation, often linked to IBS discomfort. This trial will compare active taVNS intervention with a sham taVNS to evaluate its effectiveness in managing IBS-related pain and symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Xiaomei S Cong

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young adults with Irritable Bowel Syndrome (IBS) who experience chronic pain. Participants will use a home-based device to stimulate the vagus nerve through the ear, aiming to manage IBS-related pain and symptoms. They must be able to commit to a 6-week treatment plan and attend checkups at the research lab.

Inclusion Criteria

I am either a man or a woman.

Daily access to a computer connected to the internet

I have been diagnosed with IBS and currently experience pain.

Exclusion Criteria

I have a long-term pain condition.

I have diabetes.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Run-in

Participants undergo a baseline run-in period before randomization

2 weeks

Treatment

Participants receive Active or Sham taVNS intervention for pain and symptom management

6 weeks

2 visits (in-person) at the start and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Trial Overview The study tests if using taVNS at home is feasible, safe, and satisfactory for managing IBS-related pain in young adults. It involves comparing an active taVNS intervention with a Sham version that provides minimal stimulation over six weeks of twice-daily sessions.

How Is the Trial Designed?

Group I: Active taVNS intervention Experimental Treatment 1 Intervention

Active taVNS twice daily, 30 minutes per session, over 6 weeks.

Group II: Sham taVNS Placebo Group 1 Intervention

Sham taVNS twice daily, 30 minutes per session, over 6 weeks.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (ta-VNS) was found to be effective in reducing symptoms of mild to moderate Crohn's disease and ulcerative colitis in a study of 22 pediatric patients, with 50% of Crohn's patients and 33% of ulcerative colitis patients achieving clinical remission by week 16.

The therapy also led to significant reductions in fecal calprotectin levels, with 64.7% of patients showing at least a 50% decrease, indicating a positive impact on inflammation without any safety concerns reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a proof-of-concept clinical trial. Sahn, B., Pascuma, K., Kohn, N., et al.[2023]

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]

Transcutaneous auricular vagal nerve stimulation (taVNS) significantly improved symptoms in adult patients with functional dyspepsia, with response rates of 81.2% for the 10 Hz group and 75.9% for the 25 Hz group compared to only 47% in the sham group after 4 weeks of treatment.

Both frequencies of taVNS (10 Hz and 25 Hz) were equally effective, and the benefits lasted for at least 12 weeks post-treatment, with mild adverse events reported in only 1-3% of participants, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Shi, X., Zhao, L., Luo, H., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[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) 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06847360?cond=YOUNG%20SYNDROME&rank=4

Home-based Transcutaneous Auricular Vagus Nerve ... The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain ...

2. reporter.nih.gov reporter.nih.gov/search/13EFC8094685C0D67598B8961CAA4A01A2FFCEB861BF/project-details/11122461

Project Details Home-Based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Pain and Symptom Management among Young Adults with Irritable Bowel Syndrome (IBS).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12398348/

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve ... The alleviation of IBS-C symptoms may be attributed to the integrative effects of taVNS on rectal functions, mediated through vagal, cholinergic, and multiomics ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0969996124000391

Ameliorating effects of transcutaneous auricular vagus ... We found that taVNS increased fecal pellet number, fecal water content, and gastrointestinal transit in IBS-C model mice compared with the sham-ES group.

5. bioelecmed.biomedcentral.com bioelecmed.biomedcentral.com/articles/10.1186/s42234-024-00162-5

Exploring the efficacy of Transcutaneous Auricular Vagus ... This study demonstrates that taVNS has model-dependent local and systemic effects, reducing inflammation and apoptosis in UC-like colitis while offering ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06847360/home-based-transcutaneous-auricular-vagus-nerve-stimulation-tavns-for-ibs-pain

Home-based Transcutaneous Auricular Vagus Nerve ... The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-

7. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...