Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

NCT03675321 | Completed Results DMC FDA Device

• 2 other identifiers: 1064187-21K23DK116969-01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea. A neurostimulator is applied to the outer ear and stimulates several nerves that are thought to be involved in transmission of nausea and vomiting signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Nausea Severity Scale

  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.

  After 4 weeks of therapy

Secondary Outcomes (2)

• Nausea Profile

  After 4 weeks of therapy

• Baxter Retching Faces Scale

  Average score during week 4 of therapy

Study Arms (2)

Auricular Neurostimulation

EXPERIMENTAL

Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks

Device: Active Auricular Neurostimulation

Sham Auricular Neurostimulation

SHAM COMPARATOR

Intervention: Sham (Inactive) Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks.

Device: Sham Auricular Neurostimulation

Interventions

Active Auricular Neurostimulation DEVICE

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.

Also known as: Percutaneous Electrical Nerve Field Stimulation (PENFS), Neuro-Stim System-2

Auricular Neurostimulation

Sham Auricular Neurostimulation DEVICE

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.

Also known as: Sham neurostimulation without electrical charge

Sham Auricular Neurostimulation

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 28526575 BACKGROUND

• 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.

  PMID: 27843360 BACKGROUND

• 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.

  PMID: 28826627 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Medical College of Wisconsin

ksiegel@mcw.edu

4142666131

Study Officials

• Katja Kovacic, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, investigators and study team members blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, double blind placebo-controlled trial

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: September 18, 2018
• Study Start: April 23, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: November 20, 2025
• Results First Posted: June 12, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)