Vagal Nerve Stimulation for Gastroparesis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 9/9/2018 |
| Start Date: | March 1, 2017 |
| End Date: | July 1, 2020 |
| Contact: | Emerald Adler, LMSW |
| Email: | emerald.adler@stanford.edu |
| Phone: | 6507212665 |
Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
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.
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.
Inclusion Criteria:
1. Male or female.
2. Age 21-65 years old.
3. Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as
per AGA (American Gastroenterology Association) guidelines.
4. Patient is capable of giving informed consent and undergo upper endoscopy.
5. Patient is on stable doses of other medications for gastroparesis for preceding 4
weeks prior to enrollment (baseline measures).
Exclusion Criteria
1. Surgical-related gastroparesis
2. Extrinsic myopathy or neuropathy causing gastroparesis.
3. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
4. 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.
5. Patients with severe flare requiring hospitalization.
6. Untreated significant depression or suicidal thoughts.
7. Pregnant or breast-feeding women.
8. History of gastric pacemaker implantation.
9. Patients with prior gastric surgery, including fundoplication, partial/total
gastrectomy, or gastric bypass.
10. Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
11. Patients with primary pulmonary disorders that affect the spirulina breath test.
12. Patients with implantable electronic devices.
13. Patients with carotid artery atherosclerosis.
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Linda Nguyen, MD
Phone: 650-721-2665
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