Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

October 11, 2018 updated by: Katja Kovacic, Medical College of Wisconsin

Efficacy of Auricular Neurostimulation for Adolescents With Pain-Associated Functional Gastrointestinal Disorders

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Neurostimulator
Auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
Device: Neurostimulator
Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.
SHAM_COMPARATOR: Sham Neurostimulator
Inactive auricular neurostimulator treatment x 5 days each week for 4 consecutive weeks
Device: Sham
Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Frequency-Severity-Duration Scale (PFSD) Score
Time Frame: Change from Baseline to Week 4
One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome.
Change from Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea Profile
Time Frame: Change from Baseline to week 4 in Nausea Profile score.
Two page, 17-item questionnaire which measures the subjective experience of nausea on a scale from 0 (not at all) to 9 (severely) across three dimensions: 1) somatic distress; 2) gastrointestinal distress and 3) emotional distress. Total score 153.
Change from Baseline to week 4 in Nausea Profile score.
State-Trait Anxiety Inventory for Children (STAI-C)
Time Frame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
State-Trait Anxiety Inventory for Children (STAI-C). State anxiety measured by 20-item questionnaire assessing anxiety at a particular moment in time on a 3-point rating scale. Raw scores (range 20-60) were converted to normalized T-Scores based on a population of healthy school children (mean=50; standard deviation=10) with higher score indicating worse outcome. Effects of intervention on state anxiety was assessed before (pre) and after (post) therapy.
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)
Time Frame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
A 7-item instrument that measures quality of life in relation to health. Each question has five response options (scored 1-5 units on a scale). A total raw sum score is generated, ranging from lowest score of 7 and highest score of 35 with higher scores indicating better outcome (improved quality of life). The raw score is converted to a standardized T-score (mean=50; standard deviation=10) based on a population of healthy children. T-scores were compared before (Pre) and after (Post) treatment intervention.
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
Functional Disability Inventory (FDI)
Time Frame: Change from Baseline (Pre) to 2-3 months after end of therapy (Post)
15-item instrument, each question rated on a five-point scale (0="no trouble" to 4="impossible"), indicating how much difficulty subjects have doing common childhood activities because of their physical health. A total score is summed (range 0-60) with higher score indicating worse outcome (greater pain-related disability). Scored were compared before (Pre) and after (Post) treatment intervention.
Change from Baseline (Pre) to 2-3 months after end of therapy (Post)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses
Time Frame: Baseline only (diagnostic criteria)
Nine-page, validated, parent-report questionnaire that assesses symptoms associated with pediatric functional GI disorders to diagnose the following specific Rome III criteria: Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, Functional Abdominal Pain and Functional Abdominal Pain Syndrome. The number of participants with these specific diagnoses at baseline were reported, including overlapping diagnoses.
Baseline only (diagnostic criteria)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

American Neurogastroenterology and Motility Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (ESTIMATE)

February 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KovacicK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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