NCT06360900 Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
| NCT ID | NCT06360900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-29 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-29 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06360900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06360900 currently recruiting?
Yes, NCT06360900 is actively recruiting participants. Contact the research team at klin16@mgh.harvard.edu for enrollment information.
Where is the NCT06360900 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06360900 clinical trial?
NCT06360900 is sponsored by Spaulding Rehabilitation Hospital. The trial plans to enroll 80 participants.