Functional DyspepsiaCONVERGENCT06360900
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
A study testing Sensory device, Skills Building and Health Education in people with Functional Dyspepsia, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Sensory device, Skills Building and Health Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Luca McKerley Coronado, 857-238-0962, convergestudy@mgb.org
About this study
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
- Being tested
- Sensory device, Skills Building, Health Education, Subsensory device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory deviceDevice
Sensory vagal nerve stimulation
Skills BuildingBehavioural
Skills Building behavioral therapy
Health EducationBehavioural
Education of FD condition
Subsensory deviceDevice
Subsensory vagal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sensory device + Skills Building | Experimental | Not described Receives: Device: Sensory device; Behavioral: Skills Building |
| Sensory device + Health Education | Active comparator | Not described Receives: Device: Sensory device; Behavioral: Health Education |
| Subsensory device + Skills Building | Active comparator | Not described Receives: Behavioral: Skills Building; Device: Subsensory device |
| Subsensory device + Health Education | Sham comparator | Not described Receives: Behavioral: Health Education; Device: Subsensory device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral Sensitivity Index (VSI)
GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes
Measured: 8 weeks (post-treatment)
Secondary outcomes (2)
Gastric peristaltic velocity
MRI-derived gastric motility outcome
Measured: 8 weeks (post-treatment)
Nepean Dyspepsia Index (NDI)
FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes
Measured: 8 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start29 Oct 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Sclocco, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360900
- Sponsor's protocol ID
- 2024P000849
- Other IDs
- R01DK136243
- Acronym
- CONVERGE
- Status last verified
- Oct 2025
- First submitted
- 3 Apr 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT06360900
- Acronym / sponsor ID
- CONVERGE / 2024P000849
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sensory device + Skills Building | Experimental | Device: Sensory device, Behavioral: Skills Building |
| Sensory device + Health Education | Active comparator | Device: Sensory device, Behavioral: Health Education |
| Subsensory device + Skills Building | Active comparator | Behavioral: Skills Building, Device: Subsensory device |
| Subsensory device + Health Education | Sham comparator | Behavioral: Health Education, Device: Subsensory device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory deviceSensory vagal nerve stimulation | Device | Sensory device + Health Education, Sensory device + Skills Building |
| Skills BuildingSkills Building behavioral therapy | Behavioural | Sensory device + Skills Building, Subsensory device + Skills Building |
| Health EducationEducation of FD condition | Behavioural | Sensory device + Health Education, Subsensory device + Health Education |
| Subsensory deviceSubsensory vagal nerve stimulation | Device | Subsensory device + Health Education, Subsensory device + Skills Building |
Primary outcome
Visceral Sensitivity Index (VSI)
Time frame: 8 weeks (post-treatment)
GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes
2 secondary outcomes
Gastric peristaltic velocity
Time frame: 8 weeks (post-treatment)
Nepean Dyspepsia Index (NDI)
Time frame: 8 weeks (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory device, Skills Building and Health Education in people with Functional Dyspepsia, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca McKerley Coronado (857-238-0962, convergestudy@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral Sensitivity Index (VSI) (time frame: 8 weeks (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.