Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
NCT ID: NCT03603730
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2018-11-30
2028-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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taVNS
Active or inactive taVNS
taVNS
Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.
Interventions
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taVNS
Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Braden Kuo
Principal Investigator
Principal Investigators
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Roberta Sclocco, PhD
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010P000440
Identifier Type: -
Identifier Source: org_study_id
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