Purpose

The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Age 18-65 years old (inclusive) - Ability to give written consent and participate in behavioral intervention in English - Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment - Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session - Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes - Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period

Exclusion Criteria

  • Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms - Enteral or parenteral feeding - Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders - Estimated Glomerular Filtration Rate (eGFR) < 60 - Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study - Intellectual disability by history - Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy - No active clinical acupuncture therapy - Illicit drugs or opioid usage - History of arrhythmias - Current pregnancy/breastfeeding - Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia) - Weight > 450 lbs. (limit of the MRI table) - Allergy to pineapple (used in the test meal during MRI) - Any other condition interfering with study requirements, according to the Investigator

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sensory device + Skills Building
  • Device: Sensory device
    Sensory vagal nerve stimulation
  • Behavioral: Skills Building
    Skills Building behavioral therapy
Active Comparator
Sensory device + Health Education
  • Device: Sensory device
    Sensory vagal nerve stimulation
  • Behavioral: Health Education
    Education of FD condition
Active Comparator
Subsensory device + Skills Building
  • Behavioral: Skills Building
    Skills Building behavioral therapy
  • Device: Subsensory device
    Subsensory vagal nerve stimulation
Sham Comparator
Subsensory device + Health Education
  • Behavioral: Health Education
    Education of FD condition
  • Device: Subsensory device
    Subsensory vagal nerve stimulation

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02129
Contact:
Karen Lin
617-724-6642
klin16@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Spaulding Rehabilitation Hospital

Study Contact

Karen Lin
617-724-6642
klin16@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.