Clinical trial NCT06360900: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia
Official title: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements.


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

Primary outcomes:
measure: Nepean Dyspepsia Index (NDI)
timeFrame: 8 weeks (post-treatment)
measure: Visceral Sensitivity Index (VSI)
timeFrame: 8 weeks (post-treatment)
Secondary outcomes:
measure: Gastric peristaltic velocity
timeFrame: 8 weeks (post-treatment)
Other outcomes:
Locations:
Study officials:
References: