Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Functional Disorder of Intestine, Nausea Persistent

Intervention / Treatment
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* Device: Neurostimulator
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Frequency-Severity-Duration Scale (PFSD) Score | 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 | 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) | 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) | 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) | 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) |