NCT06360900

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Oct 2025Mar 2029

First Submitted

Initial submission to the registry

April 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 29, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

November 6, 2025

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

April 3, 2024

Last Update Submit

November 4, 2025

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Visceral Sensitivity Index (VSI)

    GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes

    8 weeks (post-treatment)

Secondary Outcomes (2)

  • Gastric peristaltic velocity

    8 weeks (post-treatment)

  • Nepean Dyspepsia Index (NDI)

    8 weeks (post-treatment)

Study Arms (4)

Sensory device + Skills Building

EXPERIMENTAL
Device: Sensory deviceBehavioral: Skills Building

Sensory device + Health Education

ACTIVE COMPARATOR
Device: Sensory deviceBehavioral: Health Education

Subsensory device + Skills Building

ACTIVE COMPARATOR
Behavioral: Skills BuildingDevice: Subsensory device

Subsensory device + Health Education

SHAM COMPARATOR
Behavioral: Health EducationDevice: Subsensory device

Interventions

Sensory deviceDEVICE

Sensory vagal nerve stimulation

Sensory device + Health EducationSensory device + Skills Building
Skills BuildingBEHAVIORAL

Skills Building behavioral therapy

Sensory device + Skills BuildingSubsensory device + Skills Building
Health EducationBEHAVIORAL

Education of FD condition

Sensory device + Health EducationSubsensory device + Health Education
Subsensory deviceDEVICE

Subsensory vagal nerve stimulation

Subsensory device + Health EducationSubsensory device + Skills Building

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

Central Study Contacts

Karen Lin

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 11, 2024

Study Start

October 29, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

November 6, 2025

Record last verified: 2025-10

Locations

US(1)