NCT03863704: STIMIBD

Transcutaneous VNS to Treat Pediatric IBD

Completed NA Last updated 1 October 2024

What this trial tests

NA trial testing Transcutaneous Electrical Nerve Stimulation (TENS) in Crohn Disease in 30 participants. Completed in 31 December 2023.

Timeline

14 February 2019

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Northwell Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	14 February 2019
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous Electrical Nerve Stimulation (TENS)

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 10 to 21, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal nerve stimulation (VNS). Research has previously identified that VNS using a surgically implanted stimulator can improve symptoms and decrease inflammation in people with inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation through the skin (rather than through an implanted device) as a potential therapy in pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this nerve stimulation affects symptoms, markers of inflammation found in the blood and stool including cytokine levels, and heart rate variability. The primary hypothesis of the study is the use of transcutaneous VNS will decrease inflammation in people with IBD leading to improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include changes in symptom scores, blood cytokine levels, and heart rate variability.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Potential of Vagus Nerve Stimulation for Inflammatory Bowel Diseases.
   Bonaz B, Sinniger V, Pellissier S. · · 2021 · cited 108× · PMID 33828455 · DOI 10.3389/fnins.2021.650971
2. Anatomical and clinical implications of vagal modulation of the spleen.
   Bassi GS, Kanashiro A, Coimbra NC, Terrando N, et al · · 2020 · cited 59× · PMID 32061636 · DOI 10.1016/j.neubiorev.2020.02.011
3. Neuro-Immune Circuits Regulate Immune Responses in Tissues and Organ Homeostasis.
   Jakob MO, Murugan S, Klose CSN. · · 2020 · cited 54× · PMID 32265899 · DOI 10.3389/fimmu.2020.00308
4. Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a proof-of-concept clinical trial.
   Sahn B, Pascuma K, Kohn N, Tracey KJ, et al · · 2023 · cited 28× · PMID 37849000 · DOI 10.1186/s42234-023-00124-3
5. Cholinergic immunomodulation in inflammatory bowel diseases.
   Serafini MA, Paz AH, Nunes NS. · · 2022 · cited 16× · PMID 34977822 · DOI 10.1016/j.bbih.2021.100401
6. Vagus Nerve Stimulation and Sacral Nerve Stimulation for Inflammatory Bowel Disease: A Systematic Review.
   Pikov V. · · 2023 · cited 9× · PMID 38606364 · DOI 10.14218/jtg.2023.00098
7. Cholinergic anti-inflammatory pathway and COVID-19.
   Mehranfard D, Speth RC. · · 2022 · cited 6× · PMID 35411295 · DOI 10.34172/bi.2022.23980
8. Macrophages as central mediators of sympathetic neuro-immune interplay in autoimmunity.
   Muntjewerff EM, Josyula VS, Lehmair F, Christoffersson G. · · 2025 · PMID 41476959 · DOI 10.3389/fimmu.2025.1654382