NCT05165108: VNS

Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study

Terminated NA Results posted Last updated 6 March 2025

What this trial tests

NA trial testing Vagal Nerve Stimulator in Crohn Disease in 4 participants. Terminated before completion.

Timeline

30 November 2021

Primary endpoint
12 August 2022

12 August 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	30 November 2021
Primary completion	12 August 2022
Estimated completion	12 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Vagal Nerve Stimulator

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Indiana University

Who can join

Adults 18 to 75, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Fecal Calprotectin From Baseline to 16 Weeks Primary · Baseline and 16 weeks

This test can identify the level of inflammation in the colon of a person with Crohn's Disease. If a person diagnosed with Crohn's Disease subsequently shows low levels (50 -200 ug/mg) of fecal calprotectin, this means that the inflammation is being controlled, so the treatment regime is working.

Group	Value	95% CI
Non-Invasive VNS	-102	± 0

Change in Crohn's Disease Activity Index (CDAI) From Baseline to 16 Weeks Secondary · Baseline and 16 Weeks

CDAI range is minimum 0 and maximum 450. Zero is best score. Four hundred and fifty is the worst score. Lowering the CDAI score by 70 points or more is the goal for this study. A CDAI score of \< or = 150 is considered remission.

Group	Value	95% CI
Non-Invasive VNS	275.7	± .1

Sponsor's own description

To assess the safety and efficacy of transcutaneous vagal stimulation in adult patients with active Crohn's disease.

Publications & conference data

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

1. Clinical perspectives on vagus nerve stimulation: present and future.
   Goggins E, Mitani S, Tanaka S. · · 2022 · cited 54× · PMID 35536161 · DOI 10.1042/cs20210507
2. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124