Auricular Neurostimulation for Cyclic Vomiting Syndrome

Cyclic Vomiting Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434652
• Other study ID #: 1102505-4
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: April 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Migraine
• Cyclic Vomiting Syndrome
• Migraine Disorders
• Syndrome
• Vomiting

Intervention

Device:
• Percutaneous neurostimulation
Auricular percutaneous neurostimulation

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (4)

Babygirija R, Sood M, Kannampalli P, Sengupta JN, Miranda A. Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats. Neuroscience. 2017 Jul 25;356:11-21. doi: 10.1016/j.neuroscience.2017.05.012. Epub 2017 May 17. — View Citation

Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18. — View Citation

Miranda A, Taca A. Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Am J Drug Alcohol Abuse. 2018;44(1):56-63. doi: 10.1080/00952990.2017.1295459. Epub 2017 Mar 16. Erratum in: Am J Drug Alcohol Abuse. 2018;44(4):498. — View Citation

Roberts A, Sithole A, Sedghi M, Walker CA, Quinn TM. Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Med Devices (Auckl). 2016 Nov 3;9:389-393. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baxter Retching Faces Scale	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	Numeric pain scale	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.
Secondary	Anxiety	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.
Secondary	Health-Related Quality of Life	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.
Secondary	Disability in Children	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.
Secondary	Disability in Adults	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.
Secondary	Global symptoms	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.