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Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

Primary Purpose

Cyclic Vomiting Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Bridge device
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyclic Vomiting Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Change in Index for Nausea, Vomiting and Retching (INVR) Scores
The severity of daily nausea, vomiting and retching will be assessed using the Index for Nausea, Vomiting and Retching (INVR). This is a validated tool to measure the severity of nausea, vomiting and retching. The scores range from 0-32 with 0 being the least severe and 32 being the most severe.
Length of Stay in the Hospital (LOS)
Hospital Length of stay (LOS) in days which refers to the no of days that the patient was admitted in the inpatient ward or unit
Patient Satisfaction
A validated patient satisfaction score will be used

Full Information

First Posted
April 23, 2019
Last Updated
February 23, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04721171
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Halted prematurely Due to COVID-19 and Investigator left institution
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

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

5. Study Description

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: Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools. Obviate or reduce the need for opioids. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Vomiting Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sham versus real device
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
The Bridge device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Severity of Abdominal Pain
Description
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.
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.
Title
Change in Need for Opioids Between Device and Sham
Description
The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison
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.
Secondary Outcome Measure Information:
Title
Change in Index for Nausea, Vomiting and Retching (INVR) Scores
Description
The severity of daily nausea, vomiting and retching will be assessed using the Index for Nausea, Vomiting and Retching (INVR). This is a validated tool to measure the severity of nausea, vomiting and retching. The scores range from 0-32 with 0 being the least severe and 32 being the most severe.
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.
Title
Length of Stay in the Hospital (LOS)
Description
Hospital Length of stay (LOS) in days which refers to the no of days that the patient was admitted in the inpatient ward or unit
Time Frame
LOS will be determined at end of 1 month
Title
Patient Satisfaction
Description
A validated patient satisfaction score will be used
Time Frame
Patient satisfaction will be assessed at end of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thangam Venkatesan
Organizational Affiliation
MCW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

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