Health TrialsbyHealthPanel

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

ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSpaulding Rehabilitation Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Sensory device

    Device

    Sensory vagal nerve stimulation

  • Skills Building

    Behavioral

    Skills Building behavioral therapy

  • Health Education

    Behavioral

    Education of FD condition

  • Subsensory device

    Device

    Subsensory vagal nerve stimulation

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Sensory device + Skills BuildingExperimental treatment 2 interventions
Group B: Sensory device + Health EducationActive comparator 2 interventions
Group C: Subsensory device + Skills BuildingActive comparator 2 interventions
Group D: Subsensory device + Health EducationSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Visceral Sensitivity Index (VSI)

GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes

Time frame
8 weeks (post-treatment)

Secondary outcomes

1

Gastric peristaltic velocity

MRI-derived gastric motility outcome

Time frame
8 weeks (post-treatment)
2

Nepean Dyspepsia Index (NDI)

FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes

Time frame
8 weeks (post-treatment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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