Recruiting

taVNS & CBT

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT06360900

Conditions

Functional Dyspepsia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Sensory device

Skills Building

Health Education

Subsensory device

Study Details

Brief summary:

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.

Conditions

Functional Dyspepsia

Study ID

NCT06360900

Start date

Oct 29, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sensory device + Skills Building

active comparator: Sensory device + Health Education

active comparator: Subsensory device + Skills Building

sham comparator: Subsensory device + Health Education

Interventions

Sensory device

Sensory vagal nerve stimulation

Skills Building

Skills Building behavioral therapy

Health Education

Education of FD condition

Subsensory device

Subsensory vagal nerve stimulation

Primary outcome measure

  • Visceral Sensitivity Index (VSI) [ Time Frame: 8 weeks (post-treatment) ]

Central Contacts and Locations

Central contacts

Luca McKerley Coronado

857-238-0962convergestudy@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Luca McKerley Coronado

857-238-0962convergestudy@mgb.org

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Jul 15, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-07-15.