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NCT03120325 · ClinicalTrials.gov registry record · NA
Vagal Nerve Stimulation for Gastroparesis
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT03120325: Clinical Trial NA study, sponsored by Stanford University.
NCT03120325 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120325, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DEVICE Vagal Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-08-24 |
| Phase | NA |
Why NCT03120325 stopped before completion
NCT03120325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vagal Nerve Stimulation is the first listed.
NCT03120325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03120325 about?
NCT03120325 is a clinical study titled "Vagal Nerve Stimulation for Gastroparesis". 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 gastr...
What is the current status of trial NCT03120325?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2017-03-01. Estimated completion is 2018-08-24.
What interventions are being tested in trial NCT03120325?
The interventions under investigation include: Vagal Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03120325?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03120325's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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