Vagal Nerve Stimulation for Gastroparesis (VNS)

September 7, 2023 updated by: Linda Nguyen, Stanford University

Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Idiopathic Gastroparesis
Patients with idiopathic gastroparesis and delayed gastric emptying. 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.
Experimental: Diabetic Gastroparesis
Patients with diabetic gastroparesis and delayed gastric emptying. 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.
Experimental: Functional Dyspepsia
Patients with functional dyspepsia and normal gastric emptying. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
Time Frame: Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
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. Scored were recorded daily at each time point and scores then averaged to produce an overall score (range: 0 to 5, higher scores correspond to worse symptoms).
Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
Time Frame: Baseline and week 4 (3 hours to assess at each time point)
Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes. Higher number (longer times) indicate more severe gastroparesis.
Baseline and week 4 (3 hours to assess at each time point)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis
Time Frame: 8 weeks
The safety and tolerability of VNS in patients with gastroparesis assessed by recording any side effects or adverse events. Number of patients reporting serious or treatment related adverse events are reported
8 weeks
PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain
Time Frame: Baseline, week 4, week 8
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. Scores are summed and converted to percentiles normalized for the population (normalized T-score). 50 indicates the population mean with a standard deviation of 10. The higher the T-score, the more severe the symptoms.
Baseline, week 4, week 8
Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health
Time Frame: Baseline, week 4, week 8
The effect of VNS therapy on overall wellbeing and health as assessed by the SF-12. Score range: 0-100, higher scores correspond to better quality of life.
Baseline, week 4, week 8
Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
Time Frame: Baseline, week 4, week 8
The effect of VNS therapy on vagal tone as measured bv HRV (accounting for respiratory rate variability) using electrocardiogram (ASNAR) device. HRV is measured as an RFa value, a measure of the high-frequency heart rate (bpm^2 per hertz). Normal RFa is 0.5 to 8.0.
Baseline, week 4, week 8
Effect of VNS on Mucosal Inflammation
Time Frame: Baseline (pre-VNS) and 4 weeks (post-VNS)
Median fluorescence intensity (MFI) data were preprocessed for each cytokine through a sequence of averaging over duplicate wells, natural-logarithm transformation to reduce variance heterogeneity, and isolation and removal of plate effects. The effects of VNS therapy on gastric and small intestine inflammation was measured as average fold change across all 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).
Baseline (pre-VNS) and 4 weeks (post-VNS)
The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration.
Time Frame: Baseline (pre-VNS) and 4 weeks (post-VNS)
The effects of VNS therapy on gastric and small intestine leukocyte infiltration was measured as relative abundance (normalized ratio) of immune cells (identified via CD45 marker) to total live cells across tissue leukocytes from endoscopic mucosal biopsies before and after VNS, using flow cytometry.
Baseline (pre-VNS) and 4 weeks (post-VNS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andres Gottfried, MD PHD, Stanford University
  • Principal Investigator: Linda Nguyen, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 39839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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