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
|Condition or disease||Intervention/treatment||Phase|
|Functional Gastrointestinal Disorders||Device: Active Auricular Neurostimulation Device: Sham Auricular Neurostimulation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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|
|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|
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.
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
- 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.
- 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.
- 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.
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
|Contact: Rachel Unteutschfirstname.lastname@example.org|
|Contact: Adriane Mueller||4142665721||ADMueller@mcw.edu|
|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|
|Principal Investigator:||Katja Kovacic, MD||Medical College of Wisconsin|