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Device

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

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.

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

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
2,411 Previous Clinical Trials
17,462,915 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
~3 spots leftby Jul 2025