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Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

NCT02367729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2018-11-08

Study results available
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Summary

This study evaluates the effectiveness of a neurostimulator applied to the outer ear for adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve stimulation to a branch of the vagus nerve which is thought to be involved in transmission of pain signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.

Conditions

  • Functional Disorder of Intestine
  • Nausea Persistent

Interventions

DEVICE

Neurostimulator

Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.

DEVICE

Sham

Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.

Sponsors & Collaborators

  • American Neurogastroenterology and Motility Society

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Katja Kovacic, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2017-01-31

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 NCT02367729 on ClinicalTrials.gov