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A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

NCT04247100 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-12

Study results available
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Summary

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.

Conditions

  • Functional Gastrointestinal Disorders
  • Vagus Nerve Autonomic Disorder
  • Irritable Bowel Syndrome
  • Nausea
  • Dyspepsia

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

Active Transcutaneous Auricular Microstimulation delivered by TENS device

DEVICE

Sham Transcutaneous Electrical Nerve Stimulation

Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered

Sponsors & Collaborators

  • Gisela Grotewold Chelimsky

    lead OTHER

Principal Investigators

  • Gisela Chelimsky, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-08-23
Completion
2021-08-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04247100 on ClinicalTrials.gov