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Vagal Nerve Stimulation for Gastroparesis (VNS Trial)

N/A
Waitlist Available
Led By Linda Nguyen, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Awards & highlights

VNS Trial Summary

This trial is investigating a new form of treatment, vagal nerve stimulation, for gastroparesis, a digestive disorder. VNS is thought to increase vagal tone, which would reduce inflammation and gastrointestinal motility problems in gastroparesis patients.

VNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
Secondary outcome measures
Effect of VNS on Mucosal Inflammation
Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
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
+3 more

VNS Trial Design

3Treatment groups
Experimental Treatment
Group I: Idiopathic GastroparesisExperimental Treatment1 Intervention
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.
Group II: Functional DyspepsiaExperimental Treatment1 Intervention
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.
Group III: Diabetic GastroparesisExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagal Nerve Stimulation
2013
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,326 Total Patients Enrolled
6 Trials studying Gastroparesis
174 Patients Enrolled for Gastroparesis
Andres Gottfried, MD PHDStudy DirectorStanford University
Linda Nguyen, MDPrincipal InvestigatorStanford University
5 Previous Clinical Trials
642 Total Patients Enrolled
3 Trials studying Gastroparesis
120 Patients Enrolled for Gastroparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Indiana
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Vagal Nerve Stimulation for Gastroparesis
Linda Nguyen 2017. "Vagal Nerve Stimulation for Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03120325.
~3 spots leftby Apr 2025
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