Your session is about to expire
← Back to Search
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
No Placebo-Only Group
Summary
This trial is testing a hand-held device that stimulates the vagal nerve to help people with gastroparesis, a condition that slows down stomach emptying. The device aims to improve digestion and reduce inflammation by boosting the activity of the vagal nerve. Patients will use the device for a period of time, and their digestive health will be monitored before and after treatment.
Eligible Conditions
- Delayed Gastric Emptying
- Gastroparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,491 Previous Clinical Trials
17,519,229 Total Patients Enrolled
Andres Gottfried, MD PHDStudy DirectorStanford University
Linda Nguyen, MDPrincipal InvestigatorStanford University
5 Previous Clinical Trials
642 Total Patients Enrolled