CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled
Drug / intervention
Neurostimulator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02367729
NCT02367729N/ACompleted
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Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders

Medical College of Wisconsin·interventional·Posted Feb 20, 2015·Updated Nov 8, 2018

In Brief

A clinical study evaluating Neurostimulator and Sham for Functional Disorder of Intestine and Nausea Persistent. Completed, enrolled 115 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Disorder of Intestine, Nausea Persistent
CountriesUnited States
CollaboratorsAmerican Neurogastroenterology and Motility Society

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.4 years ago

Interventions

Neurostimulatordevice

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

Shamdevice

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