Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
50 participants
INTERVENTIONAL
2023-08-22
2028-06-30
Brief Summary
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Detailed Description
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This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Outcomes assessors will be blind to group assignments until analysis is complete.
Study Groups
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Congruent
Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.
active TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
Incongruent
Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.
active TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
Interventions
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active TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
Eligibility Criteria
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Inclusion Criteria
* Functional dyspepsia
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Vitaly Napadow, Ph.D., Lic.Ac.
Assistant Professor
Principal Investigators
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Vitaly Napadow, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard University
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009P002177
Identifier Type: -
Identifier Source: org_study_id
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