Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia (CONVERGE)

Mass General Brigham

Status: Enrolling

Conditions: Functional Dyspepsia

Treatments: Device: Subsensory device; Behavioral: Health Education; Device: Sensory device; Behavioral: Skills Building

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06360900

R01DK136243 (U.S. NIH Grant/Contract)

2024P000849

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Sensory device + Skills Building

Experimental group

Treatment:

Behavioral: Skills Building

Device: Sensory device

Sensory device + Health Education

Active Comparator group

Treatment:

Device: Sensory device

Behavioral: Health Education

Subsensory device + Skills Building

Active Comparator group

Treatment:

Behavioral: Skills Building

Device: Subsensory device

Subsensory device + Health Education

Sham Comparator group

Treatment:

Behavioral: Health Education

Device: Subsensory device