GastroparesisVNSNCT03120325

Vagal Nerve Stimulation for Gastroparesis

A study testing Vagal Nerve Stimulation in people with Gastroparesis, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Gastroparesis
What is being tested?: Vagal Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2017to 24 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Surgical-related gastroparesis
Extrinsic myopathy or neuropathy causing gastroparesis.
Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
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.
Patients with severe flare requiring hospitalization.
Untreated significant depression or suicidal thoughts.

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Pregnant or breast-feeding women.
History of gastric pacemaker implantation.
Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
Patients with primary pulmonary disorders that affect the spirulina breath test.
Patients with implantable electronic devices.
Patients with carotid artery atherosclerosis.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University Medical Center
Redwood City, California, 94063

Other trials in United States

About this study

Official title: 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.

Conditions: Gastroparesis
Being tested: Vagal Nerve Stimulation
Medical subject headings: Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vagal Nerve StimulationDevice
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 groups in NCT03120325
Study group	Role	What they receive
Idiopathic Gastroparesis	Experimental	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. Receives: Device: Vagal Nerve Stimulation
Diabetic Gastroparesis	Experimental	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. Receives: Device: Vagal Nerve Stimulation
Functional Dyspepsia	Experimental	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. Receives: Device: Vagal Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
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).
Measured: 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
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.
Measured: Baseline and week 4 (3 hours to assess at each time point)

Secondary outcomes (6)

PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain
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.
Measured: Baseline, week 4, week 8
Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health
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.
Measured: Baseline, week 4, week 8
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
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
Measured: 8 weeks
Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
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.
Measured: Baseline, week 4, week 8
Effect of VNS on Mucosal Inflammation
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).
Measured: Baseline (pre-VNS) and 4 weeks (post-VNS)
The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration.
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.
Measured: Baseline (pre-VNS) and 4 weeks (post-VNS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201724 Aug 2018

First posted19 Apr 2017
Study start1 Mar 2017
Primary completion24 Aug 2018
Study completion24 Aug 2018

Why it stopped: Recruitment challenges due to the COVID19 pandemic and funding not available to restart.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroparesisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 15 participants planned enrollment in each arm: * Diabetic Gastroparesis * Functional Dyspepsia * Idiopathic Gastoparesis
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03120325
Sponsor's protocol ID: 39839
Acronym: VNS
Status last verified: Sep 2023
First submitted: 11 Apr 2017
Last updated: 13 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis

All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
ClinicalTrials.gov ID: NCT03120325
Acronym / sponsor ID: VNS / 39839
Conditions: Gastroparesis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment challenges due to the COVID19 pandemic and funding not available to restart.
Enrolment: 24 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 1 Mar 2017 (actual)
Primary completion: 24 Aug 2018 (actual)
Study completion: 24 Aug 2018 (actual)
First posted: 19 Apr 2017 (actual)
Results: Posted 5 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 15 participants planned enrollment in each arm: * Diabetic Gastroparesis * Functional Dyspepsia * Idiopathic Gastoparesis

Arm	Type	Receives
Idiopathic Gastroparesis	Experimental	Device: Vagal Nerve StimulationPatients 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.
Diabetic Gastroparesis	Experimental	Device: Vagal Nerve StimulationPatients 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.
Functional Dyspepsia	Experimental	Device: Vagal Nerve StimulationPatients 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.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

Surgical-related gastroparesis
Extrinsic myopathy or neuropathy causing gastroparesis.
Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
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.
Patients with severe flare requiring hospitalization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vagal Nerve StimulationPatients 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.	Device	Diabetic Gastroparesis, Functional Dyspepsia, Idiopathic Gastroparesis

Primary outcome

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).
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.

6 secondary outcomes

PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain
Time frame: 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
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
Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
Time frame: Baseline, week 4, week 8
Effect of VNS on Mucosal Inflammation
Time frame: 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)

Results and safety

Results posted to the registry on 5 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Idiopathic Gastroparesis	17	15
Diabetic Gastroparesis	1	1
Functional Dyspepsia	6	5

Primary outcome: 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). Mean (Standard Deviation). Unit: score on a scale

Measure	Idiopathic Gastroparesis n = 15	Diabetic Gastroparesis n = 1	Functional Dyspepsia n = 5
Baseline	2.4 (0.76)	2.68 (NA)	2.1 (1.1)
Week 4	1.65 (1.05)	1.71 (NA)	1.7 (1.0)
Week 8	2.0 (1.09)	2.36 (NA)	1.6 (1.1)

Population analysed: Participants who received treatment are included in the analysis.

Primary outcome: 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). Mean (Standard Deviation). Unit: minutes

Measure	Idiopathic Gastroparesis n = 15	Diabetic Gastroparesis n = 1	Functional Dyspepsia n = 5
Baseline	155.1 (40.2)	140.8 (NA)	91.8 (19.8)
Week 4	129.0 (37.0)	120.7 (NA)	100.8 (37.7)

Population analysed: Participants who received treatment are included in the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through week 8. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Idiopathic Gastroparesis	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17
Diabetic Gastroparesis	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Functional Dyspepsia	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): This trial had recruitment challenges due to the COVID19 pandemic with added cost of COVID testing prior to procedures. The idiopathic gastroparesis arm completed its planned enrollment but the other cohorts did not.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Gastroparesis

Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andres Gottfried, MD PHD principal investigator

Stanford University

Linda Nguyen, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vagal Nerve Stimulation in people with Gastroparesis, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.