Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dyspepsia
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Neuroimaging
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.
Detailed Description
The primary aims of this study are to 1) investigate the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain-gut signaling using a liquid meal test in functional dyspepsia (FD) and gastroparesis (GP) patients using combined gastric, autonomic and neuroimaging measures, and 2) evaluate the effectiveness of taVNS on FD and GP symptoms. A total of 25 FD and 25 GP patients will be enrolled in this study, both females and males, ranging between 18 and 65 years of age. There will be multiple study visits consisting of a screening, baseline testing, consumption of a liquid meal, and fMRI brain and gut imaging sessions. Visits will include active and inactive taVNS delivered to the outer ear at a moderate, non-painful level.
Investigators
Braden Kuo
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Volunteers, female and male, between 18 and 65 years of age.
- •For healthy volunteers, ability to undergo MRI for up to 2 hours.
- •For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
- •For Gastroparesis patients, diagnosis will include the following criteria:
- •symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
- •an idiopathic etiology
- •abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours.
- •4\) Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period.
- •5\) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session.
Exclusion Criteria
- •History gastric/esophageal surgery
- •Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
- •Illicit drugs or opioid use.
- •History of arrhythmias.
- •Implanted pacemaker.
- •Epilepsy or a prior history of seizures.
- •For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
- •Pregnancy or nursing or plans to become pregnant.
- •Inability to provide informed consent.
- •BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
Outcomes
Primary Outcomes
Neuroimaging
Time Frame: 2 hours
Functional magnetic resonance imaging (fMRI)
Secondary Outcomes
- Electrogastrography (EGG)(2 hours)
- Respiration(2 hours)
- Electrocardiography (ECG)(2 hours)
- Skin Conductance Levels (SCL)(2 hours)