Auricular Neurostimulation for Cyclic Vomiting Syndrome

April 11, 2022 updated by: Katja Kovacic, Medical College of Wisconsin

Efficacy of Auricular Neurostimulation for Children and Adults With Cyclic Vomiting Syndrome: a Pilot Study

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting syndrome.

Study Overview

Status

Completed

Detailed Description

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

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Auricular percutaneous neurostimulation
Other Names:
  • 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).
Auricular percutaneous neurostimulation
Other Names:
  • Neuro-Stim System (NSS)-2 BRIDGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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
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.
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
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.
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
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.
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).
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 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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