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

NCT05165108 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-03-06

Study results available
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Summary

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

Conditions

  • Crohn Disease

Interventions

DEVICE

Vagal Nerve Stimulator

A handheld device which consists of a battery powered portable stimulator with a digital control user interface that controls signal amplitude and two steel contact electrodes will deliver the nVNS electrical stimulation to the cervical Vagus nerve. The device has been approved by the U.S. Food and Drug Administration (FDA) for non-invasive Vagus nerve stimulator therapy for adjunctive use for the prevention and treatment of migraine and cluster headaches in adult patients.

Sponsors & Collaborators

  • ElectroCore INC

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Sashidhar V Sagi, MD · Indiana University School of Medicine

  • Thomas V Nowak, MD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-08-12
Completion
2022-08-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165108 on ClinicalTrials.gov