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Auricular Neurostimulation for Cyclic Vomiting Syndrome

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ClinicalTrials.gov Identifier: NCT03434652
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Katja Kovacic, Medical College of Wisconsin

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cyclic Vomiting Syndrome Abdominal Migraine Device: Percutaneous neurostimulation Not Applicable

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. Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored after each therapy for the entire study as well as after the study is completed.


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 : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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).
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




Primary Outcome Measures :
  1. Nausea and vomiting [ 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 frequency of nausea and vomiting


Secondary Outcome Measures :
  1. Pain [ 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 severity of pain

  2. Anxiety [ 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. ]
    State-Trait Anxiety Inventory for Children and Adults

  3. Quality of Life [ 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. ]
    Patient Reported Outcomes Measurement Information Systems

  4. Functioning [ 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. ]
    Functional Disability Inventory

  5. Disability [ 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. ]
    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).

  6. Global symptoms [ 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. ]
    Global symptom improvement scale



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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03434652


Contacts
Contact: Rachel Unteutsch, BS 414-266-4844 runteutsch@mcw.edu
Contact: Gina Erato, BS 414-266-6728 gerato@mcw.edu

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lisa Nielson, MS    414-266-3695    lnielson@mcw.edu   
Contact: Betsy Flinn, BS    4142663915    bflinn@mcw.edu   
Principal Investigator: Katja Kovacic, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Katja Kovacic, MD Medical College of Wisconsin

Publications:
Responsible Party: Katja Kovacic, Assistant Professor of Pediatrics, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03434652     History of Changes
Other Study ID Numbers: 1102505-4
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
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
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:
Migraine Disorders
Syndrome
Vomiting
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases