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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06360900
Other study ID # 2024P000849
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date March 2029

Study information

Verified date April 2024
Source Spaulding Rehabilitation Hospital
Contact Andrew Bolender, BA
Phone 617-643-4297
Email abolender@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 2029
Est. primary completion date March 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
taVNS
Electrical transcutaneous auricular vagus nerve stimulation
Behavioral:
CBT
Cognitive Behavioral Therapy
Education Control
Education of FD condition
Device:
Sham taVNS
Sham (no current) transcutaneous auricular vagus nerve stimulation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Spaulding Rehabilitation Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Nepean Dyspepsia Index (NDI) FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes 8 weeks (post-treatment)
Primary 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 Gastric peristaltic velocity MRI-derived gastric motility outcome 8 weeks (post-treatment)
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