Auricular Neurostimulation for Cyclic Vomiting Syndrome
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ClinicalTrials.gov Identifier: NCT03434652 |
Recruitment Status :
Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Cyclic Vomiting Syndrome Abdominal Migraine | Device: Percutaneous neurostimulation | Not Applicable |
Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.
The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.
Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle. Subjects in a separate sub-study receive 6 weeks of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored before and after therapy for the entire study.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Each subject randomized to active vs sham therapy, then cross over to the other during next illness cycle |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Auricular Neurostimulation for Children and Adults With Cyclic Vomiting Syndrome: a Pilot Study |
Actual Study Start Date : | January 31, 2018 |
Estimated Primary Completion Date : | August 30, 2022 |
Estimated Study Completion Date : | August 30, 2022 |

Arm | Intervention/treatment |
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Active Comparator: Active percutaneous neurostimulation
Subject randomized to 5 days of active vs sham neurostimulation therapy during an illness cycle. With next illness cycle, each subject will cross over to the other one (active vs sham).
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Device: Percutaneous neurostimulation
Auricular percutaneous neurostimulation
Other Name: Neuro-Stim System (NSS)-2 BRIDGE |
Sham Comparator: Sham percutaneous neurostimulation
Each subject randomized to 5 days of active vs sham neurostimulation therapy during an illness cycle. With next illness cycle, each subject will cross over to the other one (active vs sham).
|
Device: Percutaneous neurostimulation
Auricular percutaneous neurostimulation
Other Name: Neuro-Stim System (NSS)-2 BRIDGE |
- Baxter Retching Faces Scale [ Time Frame: From date of baseline assessment (therapy start date) through next 7 days for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Daily nausea severity assessed by pictorial nausea faces scale 0-10 (0=no nausea; 10=worse possible nausea) with higher scores indicating worse outcomes (greater nausea).
- Numeric pain scale [ Time Frame: From date of baseline assessment (therapy start date) through next 7 days for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Daily pain severity assessed by numeric pain scale 0-10 (0=no pain; 10=worst possible pain) with higher scores indicating worse outcome (greater pain).
- Anxiety [ Time Frame: From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]State-Trait Anxiety Inventory for Children and Adults
- Health-Related Quality of Life [ Time Frame: From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Patient Reported Outcomes Measurement Information Systems
- Disability in Children [ Time Frame: From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Functional Disability Inventory
- Disability in Adults [ Time Frame: From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Sheehan Disability Scale assessing disability and impairment on a scale 0-10 with higher scores indicating more disability. Three sub scales: 1) school/work, 2) social life and 3) family life are assessed (scale 0-10) with a total score reflecting the sum of the 3 subscales (total score range 0-30 with higher score indicating more disability).
- Global symptoms [ Time Frame: From date of baseline assessment (therapy start date) and day 5 of therapy for each cycle of therapy. Also assessed at follow-up visit 3 months after end of therapy and further follow-up visits up to 12 months after end of therapy. ]Global symptom improvement scale

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Ages Eligible for Study: | 8 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meeting Rome IV Pediatric or Adult criteria for Cyclic Vomiting Syndrome (CVS)
- Concurrent abdominal pain with CVS cycle
- English-speaking
- Lack of other explanation for symptoms
- Either predictable, 'calendar-timed' episodes or prodromal symptoms for 12-24 hours that are predictive of episodes onset
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 one week of enrollment
- Infection or severe dermatological condition of ear
- Stable vital signs
- No currently implanted electrical device
- For adults (and adolescents as applicable): pregnancy, severe cardiopulmonary disease, concurrent chronic marijuana use (>2 times/month over past 6 months prior to enrollment)

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): NCT03434652
United States, Wisconsin | |
Children's Hospital of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Katja Kovacic, MD | Medical College of Wisconsin |
Responsible Party: | Katja Kovacic, Assistant Professor of Pediatrics, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT03434652 |
Other Study ID Numbers: |
1102505-4 |
First Posted: | February 15, 2018 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Migraine Disorders Syndrome Vomiting Disease Pathologic Processes Signs and Symptoms, Digestive |
Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |