Clinical trial NCT03120325: Vagal Nerve Stimulation for Gastroparesis
Official title: Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 participants planned enrollment in each arm:

* Diabetic Gastroparesis
* Functional Dyspepsia
* Idiopathic Gastoparesis
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
timeFrame: Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
measure: Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
timeFrame: Baseline and week 4 (3 hours to assess at each time point)
Secondary outcomes:
measure: PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain
timeFrame: Baseline, week 4, week 8
measure: Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health
timeFrame: Baseline, week 4, week 8
measure: 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
timeFrame: 8 weeks
measure: Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone
timeFrame: Baseline, week 4, week 8
measure: Effect of VNS on Mucosal Inflammation
timeFrame: Baseline (pre-VNS) and 4 weeks (post-VNS)
measure: The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration.
timeFrame: Baseline (pre-VNS) and 4 weeks (post-VNS)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Andres Gottfried, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Linda Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: