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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Irritable Bowel Syndrome?

Research shows that taVNS can help reduce abdominal pain and improve bowel movements in people with constipation-predominant irritable bowel syndrome (IBS-C). It has also been effective in treating other digestive issues like functional dyspepsia and inflammatory bowel diseases, suggesting it may help with IBS as well. ^{1 2 3 4 5}

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Research shows that taVNS is generally safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. There is no evidence of serious adverse effects linked to taVNS. ^{1 2 5 6 7}

How is the treatment taVNS for Irritable Bowel Syndrome different from other treatments?

taVNS is a unique treatment for Irritable Bowel Syndrome because it is a non-invasive, home-based therapy that stimulates the vagus nerve through the skin of the ear. Unlike traditional medications, it does not require surgery or drugs, making it a safe and portable option that can improve bowel movements and reduce abdominal pain. ^{1 2 8 9 10}

What is the purpose of this trial?

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 and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are: * Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? * Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms. Participants will: * Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session) * Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests * Keep a diary of their symptoms and the number of times they use the taVNS.

Research Team

Xiaomei S Cong

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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]

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 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 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]

References

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

Ameliorating effects and mechanisms of transcutaneous auricular vagal nerve stimulation on abdominal pain and constipation. [2022]

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

Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Chronic vagus nerve stimulation in Crohn's disease: a 6-month follow-up pilot study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Inflammatory Bowel Disease: Role of Vagus Nerve Stimulation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a proof-of-concept clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

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

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

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

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

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

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]