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| ID | Type | Description | Link |
|---|---|---|---|
| 3OT2OD023867-01S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congruent | Experimental | Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature. |
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| Incongruent | Experimental | Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active TEAS | Device | non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain activity during functional magnetic resonance imaging (fMRI) | Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS | 1 hour |
| Stomach activity during gastric magnetic resonance imaging (MRI) | Gastric accommodation and sensitivity change between active and inactive auricular tVNS | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Electrogastrography (EGG) | We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency. | 2 hours |
| Electrocardiography (ECG) | We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andy Bolender, B.A. | Contact | 617-643-4297 | abolender@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vitaly Napadow, PhD | Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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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.
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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.
| 2 hours |
| Respiration | Respiration will be measured in beats per minute (bpm). | 2 hours |
| Skin Conductance Levels (SCL) | SCL will be measured in volts per second. | 2 hours |