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Trial record 88 of 6732 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response

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ClinicalTrials.gov Identifier: NCT03675321
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Device: Active Auricular Neurostimulation Device: Sham Auricular Neurostimulation Not Applicable

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:

  1. To define adolescent functional nausea into subtypes based on clinical characterization and physiologic testing.
  2. 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.
  3. Investigate possible brain functional connectivity changes induced by auricular neurostimulation compared to patients with irritable bowel syndrome and healthy controls

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants, investigators and study team members blinded
Primary Purpose: Treatment
Official Title: Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Auricular Neurostimulation
Intervention: Active Percutaneous Electrical Nerve Field Stimulation (PENFS) 5 days/week x 4 weeks
Device: Active Auricular Neurostimulation
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:
  • Percutaneous Electrical Nerve Field Stimulation (PENFS)
  • Neuro-Stim System-2

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

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 Name: Sham neurostimulation without electrical charge




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nausea Profile [ Time Frame: Change from baseline total Nausea Profile score at 4 weeks. ]
    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.

  2. Baxter Retching Faces scale [ Time Frame: Change from baseline Baxter Retching Faces scale score at 4 weeks. ]
    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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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675321


Contacts
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Contact: Rachel Unteutsch 4142664844 runteutsch@mcw.edu
Contact: Adriane Mueller 4142665721 ADMueller@mcw.edu

Locations
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United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lisa Nielson, MS         
Contact: Betsy Flinn, BS         
Principal Investigator: Katja Kovacic, MD         
Sponsors and Collaborators
Medical College of Wisconsin
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Katja Kovacic, MD Medical College of Wisconsin

Publications of Results:
Other Publications:
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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03675321     History of Changes
Other Study ID Numbers: 1064187-2
1K23DK116969-01 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases