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Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.

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ClinicalTrials.gov Identifier: NCT04721171
Recruitment Status : Suspended (Due to COVID-19)
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Thangam Venkatesan, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE January 22, 2021
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE April 23, 2019
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Electrical Neurostimulation in Cyclic Vomiting Syndrome.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Sham versus real device
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cyclic Vomiting Syndrome
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: January 20, 2021)
3
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04721171
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical College of Wisconsin
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP