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NCT03675321 · ClinicalTrials.gov registry record · NA
Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response
A NA study of Functional Gastrointestinal Disorders, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT03675321: Completed NA study of Functional Gastrointestinal Disorders, sponsored by Medical College of Wisconsin.
NCT03675321 is a NA study of Functional Gastrointestinal Disorders that has completed, run by Medical College of Wisconsin. The registered enrollment target is 109 participants, below the 219-participant average among 5 other Functional Gastrointestinal Disorders trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03675321, a NA study of Functional Gastrointestinal Disorders, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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, wi
Conditions Studied
Interventions
- DEVICE Active Auricular Neurostimulation
- DEVICE Sham Auricular Neurostimulation
Study Locations (1)
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
What the finished NCT03675321 record still lists
NCT03675321 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 5 other Functional Gastrointestinal Disorders trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Functional Gastrointestinal Disorders appearing as the primary indexed condition, and to 2 interventions - of which Active Auricular Neurostimulation is the first listed.
NCT03675321 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03675321 about?
NCT03675321 is a clinical study titled "Defining Adolescent Nausea Through Brain Imaging and Neurostimulation Response". 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 transmissio...
What is the current status of trial NCT03675321?
This trial is currently completed. It is a NA study. The enrollment target is 109 participants. The study started on 2018-04-23. Estimated completion is 2022-02-28.
What conditions does trial NCT03675321 study?
This clinical trial studies the following conditions: Functional Gastrointestinal Disorders.
What interventions are being tested in trial NCT03675321?
The interventions under investigation include: Active Auricular Neurostimulation (DEVICE), Sham Auricular Neurostimulation (DEVICE).
Who is sponsoring clinical trial NCT03675321?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03675321 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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