Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Improving Vagal Tone Increase Mitochondrial Bioenergetics

NCT03931330

Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dyspepsia +1 more

COMPLETED NA

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

NCT04247100

Functional Gastrointestinal Disorders Vagus Nerve Autonomic Disorder Irritable Bowel Syndrome +2 more

TERMINATED NA

Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

NCT04706871

Functional Dyspepsia

COMPLETED NA

Effects of tVNS on Visceral Pain

NCT06659172

Healthy Females Vagus Nerve Stimulation Abdominal Pain

COMPLETED NA

Effect of Stimulation on the Vagus Nerve

NCT04206540

Healthy Subjects

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous system. It is thought to carry signals of discomfort and nausea to the brain where it is interpreted. The autonomic nervous system may be in imbalance in patients with functional gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional abdominal pain with or without nausea.

Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored weekly for the entire study as well as after the study is completed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Disorder of Intestine Nausea Persistent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neurostimulator

Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks

Group Type EXPERIMENTAL

Neurostimulator

Intervention Type DEVICE

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

Sham Neurostimulator

Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurostimulator

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

Intervention Type DEVICE

Sham

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adolescents with a major complaint of abdominal pain (minimum 3/10 in severity) with or without nausea (minimum 3/10 in severity) of unclear etiology, who are English-speaking and willing to participate and consent to the study and who have a parent willing to participate.
* Patients with symptoms of minimum three times per week for a duration of two months or greater
* Intact external ear that is free of infection or severe dermatological conditions.
* Stable vital signs for their respective age

Exclusion Criteria

* Medically complex children or those who take a medication or suffer from an organic disease that can explain symptoms will be excluded from participation.
* Children or parents, who have developmental delay, will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms.
* History of seizures
* Currently implanted electrical device
* Orthostatic hypotension

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No