Last updated: October 17, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Bowel Dysfunction
Colic
Heartburn (Pediatric)
Treatment
taVNS
Clinical Study ID
NCT03603730
2010P000440
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 forboth 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 becontinuous) with varying degrees of nausea, vomiting, early satiety, and/orpost-prandial fullness
- an idiopathic etiology
- abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat EggBeaters® protocol within the last 6 months with either a gastric emptying rate > 60% retention at 2 hours and/or >10% retention at 4 hours.
- Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month beforestudy and during the study period.
- Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session.
Exclusion
Exclusion Criteria:
- History gastric/esophageal surgery
- Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to thestudy 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 (includingallergy 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).
- Contraindications for MRI: High magnetic fields may pose a serious health hazard tosubjects with implanted ferromagnetic objects. Every subject in this study will becarefully screened before entering the high magnetic field shielded room to collect aprecise outline of the subject's medical history. Subjects with the followingcharacteristics/disease may not be eligible to participate in the study and willrequire 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
Study Design
Total Participants: 65
Treatment Group(s): 1
Primary Treatment: taVNS
Phase: 1
Study Start date:
November 30, 2018
Estimated Completion Date:
March 30, 2025
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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