Vagal Nerve Stimulation for Gastroparesis (VNS)
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|ClinicalTrials.gov Identifier: NCT03120325|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2017
Last Update Posted : March 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Device: Vagal Nerve Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Two Active Cohorts:
Diabetic Gastroparesis (n=15) Functional Dyspepsia (n=15)
Idiopathic Gastoparesis (n =15) - Target enrollment met, no longer enrolling.
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Vagal Nerve Stimulation
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.
Device: 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.
- Effect of Vagal Nerve Stimulation on gastroparesis symptoms as measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) questionnaire. [ Time Frame: up to 8 weeks (2 weeks prior to stimulation, 4 weeks of stimulation, 2 weeks after stimulation). Data analysis will occur at the 1 year mark after enrollment has stopped. ]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.
- Effect of Vagal Nerve Stimulation on the gastric emptying spirulina breath test emptying time [ Time Frame: Gastric emptying testing will occur at visit 3 (the very first day of VNS treatment) and then again at visit 5 (which occur after four weeks of VNS treatment). Data analysis will occur at the 1 year mark when enrollment has stopped. ]Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes.
- The effect of VNS therapy on overall pain [ Time Frame: Up to 8 weeks (beginning at visit 1) ]The effect of VNS therapy on overall pain interference as assessed by the PROMIS (Patient Reported Outcomes Measurement Information System) pain interference questionnaire which is a 6 item questionnaire on a 5 point scale to assess the impact of pain on daily life. The higher the score, the more severe the symptoms
- The effect of VNS therapy on overall wellbeing and health [ Time Frame: Up to 8 weeks (beginning at visit 1) ]The effect of VNS therapy on overall wellbeing and health as assessed by the short form 12 (SF-12).
- The safety and tolerability of VNS in patients with gastroparesis will be assessed [ Time Frame: Up to 8 weeks (beginning at visit 1) ]The safety and tolerability of VNS in patients with gastroparesis will be assessed by recording any side effects or adverse events. Number of patients reporting treatment related adverse events will be reported
- The effect of VNS therapy on vagal tone [ Time Frame: Up to 7 weeks (beginning at visit 3) ]The effect of VNS therapy on vagal tone as assessed bv heart rate variability (HRV) and respiratory rate variability using electrocardiogram (ASNAR) device and an HRV App called Heart Rate Variability Camera.
- Effect of VNS on mucosal inflammation [ Time Frame: Up to 4 weeks ]The effects of VNS therapy on gastric and small intestine inflammation will be explored by measurement of tissue cytokines from endoscopic mucosal biopsies before and after VNS, using cytokine multiplex assays, which report relative levels of various cytokines as adjusted mean fluorescence intensity (MFI). Results for individual cytokines will be reported as % change comparing pre VNS and post VNS levels.
- The effect of VNS therapy on gastric and small intestine leukocyte infiltration. [ Time Frame: Up to 4 weeks ]The effects of VNS therapy on gastric and small intestine leukocyte infiltration will be explored by measurement of tissue leukocytes from endoscopic mucosal biopsies before and after VNS, using flow cytometry. Results for individual immune cell types (macrophages, mast cells, T cells, B cells, etc.) will be reported as frequencies as well as absolute numbers of cells, comparing pre VNS and post VNS levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120325
|United States, California|
|Stanford University Medical Center|
|Redwood City, California, United States, 94063|
|Study Director:||Andres Gottfried, MD PHD||Stanford University|