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Vagal Nerve Stimulation for Gastroparesis (VNS)

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ClinicalTrials.gov Identifier: NCT03120325
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Nguyen, Stanford University

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.


Condition or disease Intervention/treatment Phase
Gastroparesis Device: Vagal Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Three cohorts:

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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Effect of Vagal Nerve Stimulation on gastroparesis symptoms as measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) 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. ]
    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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120325


Contacts
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Contact: Alexandria George, BS 650-723-6815 alexandria.george@stanford.edu
Contact: Linda Nguyen, MD 6507365555 nguyenlb@stanford.edu

Locations
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United States, California
Stanford University Medical Center Recruiting
Redwood City, California, United States, 94063
Contact: Alexandria George, BS    650-723-6815    alexandria.george@stanford.edu   
Contact: Linda nguyenlb@stanford.edu, MD         
Principal Investigator: Linda Nguyen, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Andres Gottfried, MD PHD Stanford University

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Responsible Party: Linda Nguyen, Clinical Associate Professor, Medicine - Gastroenterology & Hepatology, Stanford University
ClinicalTrials.gov Identifier: NCT03120325     History of Changes
Other Study ID Numbers: 39839
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms