Vagal Nerve Stimulation for Gastroparesis (VNS)
Gastroparesis
About this trial
This is an interventional treatment trial for Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Male or female.
- Age 21-65 years old.
- Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
- Patient is capable of giving informed consent and undergo upper endoscopy.
- Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).
Exclusion Criteria
- Surgical-related gastroparesis
- Extrinsic myopathy or neuropathy causing gastroparesis.
- Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
- Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible.
- Patients with severe flare requiring hospitalization.
- Untreated significant depression or suicidal thoughts.
- Pregnant or breast-feeding women.
- History of gastric pacemaker implantation.
- Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
- Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
- Patients with primary pulmonary disorders that affect the spirulina breath test.
- Patients with implantable electronic devices.
- Patients with carotid artery atherosclerosis.
Sites / Locations
- Stanford University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Idiopathic Gastroparesis
Diabetic Gastroparesis
Functional Dyspepsia
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.
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.
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.