Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

NCT03931330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-06-21

Study results available
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Summary

This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.

Conditions

  • Functional Gastrointestinal Disorders
  • Irritable Bowel Syndrome
  • Dyspepsia
  • Functional Abdominal Pain Syndrome

Interventions

DEVICE

Percutaneous neurostimulation

Percutaneous neurostimulation using NSS-2 Bridge device

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Gisela Chelimsky, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2019-09-24
Completion
2019-09-24
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 NCT03931330 on ClinicalTrials.gov