Auricular Neurostimulation for Cyclic Vomiting Syndrome

NCT03434652 | Completed Results FDA Device

• 1 other identifier: 1102505-4
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyclic Vomiting Syndrome; Abdominal Migraine

Outcome Measures

Primary Outcomes (1)

• Rhodes Index of Nausea, Vomiting & Retching (INVR)

  Acute therapy arm: Daily nausea and vomiting severity assessed by validated scale 0-32 (0=no symptoms; 32=worse possible nausea/vomiting) with higher scores indicating worse outcomes (greater nausea/vomiting). Daily scores for baseline (day 1) and end of therapy (day 7) were compared for both active and sham groups. Chronic therapy arm: Daily nausea and vomiting severity assessed by validated scale 0-32 (0=no symptoms; 32=worse possible nausea/vomiting) with higher scores indicating worse outcomes (greater nausea/vomiting). Daily scores were averaged for each week of the 6 weeks of therapy and compared between a baseline assessment and week 6 of therapy.

  Acute arm: at the start of the first and second illness cycle through next 7 days for each illness cycle (active and sham therapy). Chronic arm: from date of baseline assessment (therapy start date) through 6 weeks of therapy.

Secondary Outcomes (6)

• Numeric Pain Scale

  From date of baseline assessment (therapy start date) through next 7 days for each cycle of therapy with day 7 reported as end of therapy.

• Anxiety

  From date of baseline assessment (therapy start date) to end of therapy. For Chronic therapy arm, end of therapy= 6 weeks. For Acute therapy arm, end of therapy = day 7 (on site).

• Patient Reported Outcomes Measurement Information Systems- Health-Related Quality of Life

  From date of baseline assessment (therapy start date) to end of therapy and at 3 months follow-up. For Chronic therapy arm, end of therapy = 6 weeks. For Acute therapy arm, end of therapy = day 7.

• Functional Disability Inventory- Disability in Children

  From date of baseline assessment (therapy start date) to end of therapy and 3 months follow-up. For Chronic therapy arm, end of therapy = 6 weeks. For Acute therapy arm, end of therapy = 7 days.

• Disability in Adults

  Anticipated assessment from date of baseline assessment (therapy start date) and end of therapy for each cycle of therapy as well as follow-up visit after end of therapy. However, no adult participants were enrolled.

Study Arms (2)

Acute therapy: active vs sham percutaneous neurostimulation

SHAM COMPARATOR

Subject randomized to 5 days of active or sham neurostimulation therapy during the first illness cycle. With the second illness cycle, each subject will then cross over to the other therapy (active or sham).

Device: Percutaneous neurostimulation

Chronic therapy: active (open-label) percutaneous neurostimulation

EXPERIMENTAL

Each subject receives 6 consecutive weeks of active (open-label) neurostimulation therapy.

Device: Percutaneous neurostimulation

Interventions

Percutaneous neurostimulation DEVICE

Auricular percutaneous neurostimulation

Also known as: Neuro-Stim System (NSS)-2 BRIDGE

Acute therapy: active vs sham percutaneous neurostimulation; Chronic therapy: active (open-label) percutaneous neurostimulation

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (5)

• 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.

  PMID: 28826627 BACKGROUND

• 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.

  PMID: 28526575 BACKGROUND

• 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.

  PMID: 28301217 BACKGROUND

• 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. doi: 10.2147/MDER.S107426. eCollection 2016.

  PMID: 27843360 BACKGROUND

• Karrento K, Zhang L, Conley W, Qazi Z, Venkatesan T, Simpson P, Li BUK. Percutaneous electrical nerve field stimulation improves comorbidities in children with cyclic vomiting syndrome. Front Pain Res (Lausanne). 2023 Jun 14;4:1203541. doi: 10.3389/fpain.2023.1203541. eCollection 2023.

  PMID: 37389229 DERIVED

MeSH Terms

Conditions

Familial cyclic vomiting syndrome; Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Katherine Siegel, Research Manager, Division of Pediatric Gastroenterology
• Organization: Medical College of Wisconsin

ksiegel@mcw.edu

4142663915

Study Officials

• Katja Kovacic, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, cross over study for Arm 1 (Acute treatment) only Arm 2: open-label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Arm 1 (Acute treatment): Each subject randomized to active vs sham therapy during 1st illness cycle after enrollment, then cross over to the other (active vs sham) during the 2nd illness cycle. Arm 2 (Chronic treatment): Active, chronic (prophylactic) therapy (open label) x 6 consecutive weeks of intervention.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 15, 2018
• Study Start: January 31, 2018
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)