Clinical trial NCT03603730: Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
Official title: Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Dyspepsia
Gastroparesis
Keywords: Functional Dyspepsia
Gastroparesis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

1. Volunteers, female and male, between 18 and 65 years of age.
2. For healthy volunteers, ability to undergo MRI for up to 2 hours.
3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
4. 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:

1. History gastric/esophageal surgery
2. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
3. Illicit drugs or opioid use.
4. History of arrhythmias.
5. Implanted pacemaker.
6. Epilepsy or a prior history of seizures.
7. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
8. Pregnancy or nursing or plans to become pregnant.
9. Inability to provide informed consent.
10. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
11. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease may not be eligible to participate in the study and will require additional screening:

    * History of Head Trauma
    * Any metallic implants (e.g. braces or permanent retainers)
    * Tattoos with metallic ink above the nipple line
    * Surgical Aneurysm Clips
    * Cardiac Pacemaker
    * Prosthetic Heart Valve
    * Neurostimulator
    * Implanted pumps
    * Cochlear Implants
    * Metal rods, Plates, Screws
    * Recent Previous Surgery
    * IUD
    * Hearing Aid
    * Dentures (which might create NMR artifacts)
    * Metal Injury to eyes
    * Pregnancy or plans to become pregnant
    * Breast Feeding
    * Meniere's Disease
    * Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
    * Claustrophobia

Primary outcomes:
measure: Neuroimaging
timeFrame: 2 hours
Secondary outcomes:
measure: Electrogastrography (EGG)
timeFrame: 2 hours
measure: Electrocardiography (ECG)
timeFrame: 2 hours
measure: Respiration
timeFrame: 2 hours
measure: Skin Conductance Levels (SCL)
timeFrame: 2 hours
Other outcomes:
measure: Liquid meal challenge
timeFrame: 40 minutes
measure: Short Form Nepean Dyspepsia Index (SF-NDI)
timeFrame: 5 minutes
measure: Brief Pain Inventory (BPI)
timeFrame: 5 minutes
measure: Visual Analog Scale (VAS)
timeFrame: 5 minutes
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Roberta Sclocco, PhD
role: PRINCIPAL_INVESTIGATOR
References: