- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675321
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
By stimulating branches of several cranial nerves in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional nausea.
The study has the following specific aims:
- To define adolescent functional nausea into subtypes based on clinical characterization and physiologic testing.
- Evaluating the efficacy of auricular neurostimulation via PENFS for functional 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. Those who do not improve will receive an additional 4 weeks of therapy with active stimulation.
- Investigate possible brain functional connectivity changes induced by auricular neurostimulation compared to patients with irritable bowel syndrome and healthy controls
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meeting pediatric Rome IV criteria for functional nausea
- English-speaking and able to verbalize their condition and concerns about nausea, pain and other symptoms
- Lack of other explanation for symptoms
- Intact external ear that is free of infection or severe dermatological conditions, - - No currently implanted electrical device
Exclusion Criteria:
- Medically complex and/or suffering from medical condition that may explain symptoms
- Taking a medication that may explain symptoms
- Significant developmental delays
- Patients treated with a new drug affecting the central nervous system within 4 weeks of study start
- Infection or severe dermatological condition of ear
- Currently implanted electrical device
- Patients with a history of severe allergy to adhesives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auricular Neurostimulation
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
|
Active auricular neurostimulation for 4 weeks.
Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
Other Names:
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Sham Comparator: Sham Auricular Neurostimulation
Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.
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Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge. Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea Severity Scale
Time Frame: Change from baseline Nausea Severity Scale score at 4 weeks.
|
Measures 1) frequency of nausea on a scale 0-4 over past week (0=not at all; 4=every day), 2) average number of nausea episodes/day over past week on a scale 0-4 (0=none; 4=constant), 3) average duration of nausea episodes over past week on scale 0-4 (0=none; 4=most or all of day) and 4) severity of nausea on scale 0-10 (0=none;10=most nausea possible).
The severity subscale is converted to a 5 point scale ranging from 0-4.
The mean of all 4 subscales yields a total score ranging from 0 to 4, with a higher score indicating more severity.
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Change from baseline Nausea Severity Scale score at 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea Profile
Time Frame: Change from baseline total Nausea Profile score at 4 weeks.
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Measures 3 dimensions of nausea (Emotional, GI and Somatic distress) with 17 items.
Each sub scale is measured on a 10-point scale from 0-9 (0=not at all; 9=severely).
Total score is calculated as follows: actual score/153 * 100%.
Subscales are similarly computed into a percentage score.
Higher percentage indicates worse outcomes.
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Change from baseline total Nausea Profile score at 4 weeks.
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Baxter Retching Faces Scale
Time Frame: Change from baseline Baxter Retching Faces scale score at 4 weeks.
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Measures daily nausea severity on a pictorial faces scale from 0-10 (0=no nausea; 10=most nausea possible).
Weekly averages will be computed and change from baseline to average severity during last week of therapy will be assessed.
Higher values indicate worse outcome.
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Change from baseline Baxter Retching Faces scale score at 4 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katja Kovacic, MD, Medical College of Wisconsin
Publications and helpful links
General Publications
- Babygirija R, Sood M, Kannampalli P, Sengupta JN, Miranda A. Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats. Neuroscience. 2017 Jul 25;356:11-21. doi: 10.1016/j.neuroscience.2017.05.012. Epub 2017 May 17.
- Roberts A, Sithole A, Sedghi M, Walker CA, Quinn TM. Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Med Devices (Auckl). 2016 Nov 3;9:389-393. doi: 10.2147/MDER.S107426. eCollection 2016.
- Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1064187-2
- 1K23DK116969-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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