Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

• ClinicalTrials.gov Identifier: NCT04721171
• Recruitment Status: Suspended
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Sponsor: Medical College of Wisconsin
• Information provided by (Responsible Party): Thangam Venkatesan, Medical College of Wisconsin

Tracking Information

• First Submitted Date: April 23, 2019
• First Posted Date: January 22, 2021
• Last Update Posted Date: January 22, 2021
• Actual Study Start Date: April 23, 2019
• Actual Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 20, 2021)

• Change in severity of abdominal pain [ Time Frame: 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. ]
  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.
• Change in need for opioids between device and sham [ Time Frame: 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. ]
  The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 20, 2021)

• Change in severity of daily nausea, vomiting and retching will be aassessed using the Index for Nausea, Vomiting and Retching (INVR) [ Time Frame: 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. ]
  The severity of daily nausea, vomiting and retching will be assessed using the Index for Nausea, Vomiting and Retching (INVR) is a validated tool to measure the severeity of nausea, vomiting and retching. The scores range from 0-32 with o being the least severe and 4 being the most severe.
• Length of stay in the hospital (LOS) [ Time Frame: LOS will be determined at end of 1 month ]
  Length of stay (LOS) in days
• Patient satisfaction [ Time Frame: Patient satisfaction will be assessed at end of 1 month ]
  A validated patient satisfaction score will be used

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.
• Official Title: Effectiveness of Electrical Neurostimulation as an Opioid-Sparing Alternative in the Treatment of Cyclic Vomiting Syndrome.

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

This approach will specifically address the current opioid problem using a novel, non-invasive neurostimulation therapy with proven efficacy for opioid withdrawal. Long-term, it may improve health care outcomes and significantly reduce overall health care costs.

Detailed Description

Opioid use in CVS and the critical need for opioid sparing therapy

Given the lack of knowledge about pathophysiology and evidence-based therapies, patients are often hospitalized to treat symptoms of CVS. During an episode, patients present with severe vomiting and abdominal pain and are treated empirically with IV fluids, antiemetics, benzodiazepines, and opioids. Estimates of opioid use range from 23%-27% in adults with CVS. Patients are often dissatisfied with the level of analgesia as recurrent opioid use results in tolerance and dependence. This often undermines the physician-patient relationship and patients even leave against medical advice out of frustration with what they perceive as ineffective care. This can lead to worse outcomes including recurrent hospitalizations, morbidity and increased health care costs.

Preliminary data from a study by our group reveals that of 101 patients hospitalized with CVS at Froedtert Hospital, chronic opioid therapy is associated with a two-fold increased risk of hospitalization (RR 2.22, CI 1.1-4.4, P=0.02) and three-fold increase in hospital length of stay (LOS) (RR 3.43, CI 1.26-9.34, P=0.01). In a study of 132 CVS patients, opioid use was associated with non-response to amitriptyline (53% vs 15%, p<0.05), a prophylactic therapy used in CVS. This in turn was associated with increased frequency and duration of CVS episodes per year and increased number of hospitalizations/emergency department (ED) visits at baseline (18% vs 15.2%, p<0.05). Hence there is an urgent need for an opioid-sparing, non-invasive strategy to treat CVS symptoms.

In summary, CVS is common and disabling and is associated with significant health care costs. Our proposed project using a novel, non-invasive device to treat CVS will also address the current opioid crisis.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Sham versus real device

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Cyclic Vomiting Syndrome

Intervention

Device: The Bridge 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.

Study Arms

• Active Comparator: Intervention group
  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.
  Intervention: Device: The Bridge device
• Sham Comparator: Placebo Group
  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.
  Intervention: Device: The Bridge device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Actual Enrollment (submitted: January 20, 2021): 3
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2021
• Actual Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04721171
• Other Study ID Numbers: PRO00032752
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: NA. Our data will only be made available to the study team at the Medical College of Wisconsin as noted in the IRB

• Responsible Party: Thangam Venkatesan, Medical College of Wisconsin
• Study Sponsor: Medical College of Wisconsin
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medical College of Wisconsin
• Verification Date: January 2021