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Vagal Nerve Stimulation for Gastroparesis (VNS)

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ClinicalTrials.gov Identifier: NCT03120325
Recruitment Status : Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Linda Nguyen, Stanford University

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • Effect of Vagal Nerve Stimulation on gastroparesis symptoms as measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) questionnaire. [ Time Frame: up to 8 weeks (2 weeks prior to stimulation, 4 weeks of stimulation, 2 weeks after stimulation). Data analysis will occur at the 1 year mark after enrollment has stopped. ]
    Investigators will send daily GCSI-DD to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. Investigators hypothesize a change of more than 0.75 points.
  • Effect of Vagal Nerve Stimulation on the gastric emptying spirulina breath test emptying time [ Time Frame: Gastric emptying testing will occur at visit 3 (the very first day of VNS treatment) and then again at visit 5 (which occur after four weeks of VNS treatment). Data analysis will occur at the 1 year mark when enrollment has stopped. ]
    Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
Effect of Vagal Nerve Stimulation on gastroparesis symptoms as measures by the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire. [ Time Frame: 8 weeks (2 weeks prior to stimulation, 4 weeks of stimulation, 2 weeks after stimulation). Data analysis will occur at the 1 year mark after enrollment has stopped. ]
We will send daily GCSI's to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. We hypothesize that we will see a change of more than 1 point.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • The effect of VNS therapy on overall pain [ Time Frame: Up to 8 weeks (beginning at visit 1) ]
    The effect of VNS therapy on overall pain interference as assessed by the PROMIS (Patient Reported Outcomes Measurement Information System) pain interference questionnaire which is a 6 item questionnaire on a 5 point scale to assess the impact of pain on daily life. The higher the score, the more severe the symptoms
  • The effect of VNS therapy on overall wellbeing and health [ Time Frame: Up to 8 weeks (beginning at visit 1) ]
    The effect of VNS therapy on overall wellbeing and health as assessed by the short form 12 (SF-12).
  • The safety and tolerability of VNS in patients with gastroparesis will be assessed [ Time Frame: Up to 8 weeks (beginning at visit 1) ]
    The safety and tolerability of VNS in patients with gastroparesis will be assessed by recording any side effects or adverse events. Number of patients reporting treatment related adverse events will be reported
  • The effect of VNS therapy on vagal tone [ Time Frame: Up to 7 weeks (beginning at visit 3) ]
    The effect of VNS therapy on vagal tone as assessed bv heart rate variability (HRV) and respiratory rate variability using electrocardiogram (ASNAR) device and an HRV App called Heart Rate Variability Camera.
  • Effect of VNS on mucosal inflammation [ Time Frame: Up to 4 weeks ]
    The effects of VNS therapy on gastric and small intestine inflammation will be explored by measurement of tissue cytokines from endoscopic mucosal biopsies before and after VNS, using cytokine multiplex assays, which report relative levels of various cytokines as adjusted mean fluorescence intensity (MFI). Results for individual cytokines will be reported as % change comparing pre VNS and post VNS levels.
  • The effect of VNS therapy on gastric and small intestine leukocyte infiltration. [ Time Frame: Up to 4 weeks ]
    The effects of VNS therapy on gastric and small intestine leukocyte infiltration will be explored by measurement of tissue leukocytes from endoscopic mucosal biopsies before and after VNS, using flow cytometry. Results for individual immune cell types (macrophages, mast cells, T cells, B cells, etc.) will be reported as frequencies as well as absolute numbers of cells, comparing pre VNS and post VNS levels.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
Effect of Vagal Nerve Stimulation on the gastric emptying spirulina breath test emptying time [ Time Frame: Gastric emptying testing will occur at visit 3 (the very first day of VNS treatment) and then again at visit 5 (which occur after four weeks of VNS treatment). Data analysis will occur at the 1 year mark when enrollment has stopped. ]
We will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vagal Nerve Stimulation for Gastroparesis
Official Title  ICMJE Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
Brief Summary

This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment.

There are 6 research visits

Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout)

Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study.

The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase.

Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Two Active Cohorts:

Diabetic Gastroparesis (n=15) Functional Dyspepsia (n=15)

Closed Cohort:

Idiopathic Gastoparesis (n =15) - Target enrollment met, no longer enrolling.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE Device: Vagal Nerve Stimulation
Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.
Study Arms  ICMJE Experimental: Vagal Nerve Stimulation
All patients in trial will be giving themselves vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks starting at visit 3 and ending at visit 5.
Intervention: Device: Vagal Nerve Stimulation
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female.
  2. Age 21-65 years old.
  3. Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
  4. Patient is capable of giving informed consent and undergo upper endoscopy.
  5. Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).

Exclusion Criteria

  1. Surgical-related gastroparesis
  2. Extrinsic myopathy or neuropathy causing gastroparesis.
  3. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
  4. Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible.
  5. Patients with severe flare requiring hospitalization.
  6. Untreated significant depression or suicidal thoughts.
  7. Pregnant or breast-feeding women.
  8. History of gastric pacemaker implantation.
  9. Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
  10. Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
  11. Patients with primary pulmonary disorders that affect the spirulina breath test.
  12. Patients with implantable electronic devices.
  13. Patients with carotid artery atherosclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03120325
Other Study ID Numbers  ICMJE 39839
Has Data Monitoring Committee No
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Linda Nguyen, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andres Gottfried, MD PHD Stanford University
PRS Account Stanford University
Verification Date March 2021

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