Vagal Nerve Stimulation for Gastroparesis

NCT ID: NCT03120325

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-08-24

Brief 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.

Conditions

Gastroparesis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Idiopathic Gastroparesis

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 Type: EXPERIMENTAL

Vagal Nerve Stimulation

Intervention Type: DEVICE

Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.

Diabetic Gastroparesis

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.

Group Type: EXPERIMENTAL

Vagal Nerve Stimulation

Intervention Type: DEVICE

Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.

Functional Dyspepsia

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 Type: EXPERIMENTAL

Vagal Nerve Stimulation

Intervention Type: DEVICE

Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.

Interventions

Vagal Nerve Stimulation

Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Linda Nguyen

Clinical Associate Professor, Medicine - Gastroenterology & Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andres Gottfried, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Linda Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

39839

Identifier Type: -

Identifier Source: org_study_id