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Device

Vagal Nerve Stimulation for Delayed Gastric Emptying (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)

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

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 more

Awards & 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

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