Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

NCT04721171 | Terminated Results FDA Device

• 1 other identifier: PRO00032752
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hypothesize that 2) PENFS reduces the length of stay (LOS), and improves patient satisfaction. We propose the following specific aim: Aim 1. Investigate the efficacy of PENFS compared to a sham in patients with CVS seen in the ED or in the clinic or hospitalized with an acute CVS episode. Objectives:

1. 1.Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools.
2. 2.Obviate or reduce the need for opioids.
3. 3.Reduce the length of hospital stay and improve patient satisfaction.

Conditions

Cyclic Vomiting Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in Severity of Abdominal Pain

  Abdominal pain will be assessed through Visual Analog Scale with the score of ranging from 0 to 10, with 0 being the least and 10 being the worst pain.

  The change in abdominal pain will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.

• Change in Need for Opioids Between Device and Sham

  The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison

  The dose of opioids use ( morphine equivalent) will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.

Secondary Outcomes (3)

• Change in Index for Nausea, Vomiting and Retching (INVR) Scores

  The INVR scores will be assessed be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.

• Length of Stay in the Hospital (LOS)

  LOS will be determined at end of 1 month

• Patient Satisfaction

  Patient satisfaction will be assessed at end of 1 month

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.

Device: The Bridge device

Placebo Group

SHAM COMPARATOR

The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days.

Device: The Bridge device

Interventions

The Bridge device DEVICE

he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.

Intervention group; Placebo Group

Eligibility Criteria

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

You may qualify if:

• Patients who meet Rome criteria for cyclic vomiting syndrome and are in an acute episode.

You may not qualify if:

• Developmental delay
• Non-English speaking patients
• Pregnancy
• Any implanted electrical device
• Any significant dermatological/infectious condition of the ear

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Limitations and Caveats

The study was terminated due to COVID. There was a multidisciplinary team that was assembled which consisted of the emergency departments, hospitalists and gastroenterologist. Due to the unprecedented crisis which involved lockdowns, and furloughs we lost our resources and the ability to continue the study or collect data. We will be revising our plan on lessons learned during this study and will start a new protocol with changes and to solve COVID-related issues that are a barrier.

Results Point of Contact

• Title: Thangam Venkatesan
• Organization: Medical College of Wisconsin

tvenkate22@gmail.com

262-226-9632

Study Officials

• Thangam Venkatesan

  MCW

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sham versus real device

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: January 22, 2021
• Study Start: April 23, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 9, 2021
• Last Updated: April 2, 2026
• Results First Posted: February 14, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)