Healthy
Conditions
Keywords
Acupuncture, Magnetic Resonance Imaging, Functional, Brain Mapping, healthy volunteers, Neuromodulation, gastric MRI
Brief summary
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Detailed description
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring. 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.
Interventions
DEVICEactive TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
Sponsors
National Institutes of Health (NIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are not made aware of the expectation manipulation nor their group assignment until the end of the final visit, at which point they are debriefed. Outcomes assessors will be blind to group assignments until analysis is complete.
Intervention model description
Participants will be randomized 1:1 to Congruent or Incongruent briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 18-65 * Functional dyspepsia
Exclusion criteria
* Any condition contraindicating an fMRI brain scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain activity during functional magnetic resonance imaging (fMRI) | 1 hour | Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS |
| Stomach activity during gastric magnetic resonance imaging (MRI) | 30 minutes | Gastric accommodation and sensitivity change between active and inactive auricular tVNS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrogastrography (EGG) | 2 hours | We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency. |
| Electrocardiography (ECG) | 2 hours | We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex. |
| Respiration | 2 hours | Respiration will be measured in beats per minute (bpm). |
| Skin Conductance Levels (SCL) | 2 hours | SCL will be measured in volts per second. |
Countries
United States
Contacts
Primary ContactAndy Bolender, B.A.
Outcome results
None listed