Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation

NCT05987813 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-12-27

Study results available
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Summary

This study is to determine if the auricular microstimulator produces the expected increase in HRV.

Conditions

  • Functional Gastrointestinal Disorders

Interventions

DEVICE

TENS Unit

Usage of the Transcutaneous Electrical Nerve Stimulation device for 2 hours a day.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Gisela Chelimsky, MD · VCU

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-06-04
Completion
2024-06-04
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 NCT05987813 on ClinicalTrials.gov