Mapping Auricular Vagus Nerve Circuitry
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|ClinicalTrials.gov Identifier: NCT00200889|
Recruitment Status : Recruiting
First Posted : September 20, 2005
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: active auricular tVNS Device: inactive auricular tVNS||Early Phase 1|
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 vagus nerve stimulation, which is non-invasive and non-painful, affects human brain 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 2 functional magnetic resonance imaging (fMRI) brain-gut scans and 2 behavioral visits consisting of a nutrient drink test, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: auricular tVNS
active and inactive auricular transcutaneous vagus nerve stimulation (tVNS)
Device: active auricular tVNS
non-painful active auricular tVNS will be delivered to the left ear
Device: inactive auricular tVNS
non-painful inactive auricular tVNS will be delivered to the left ear
- Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ]Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS
- Stomach activity during gastric magnetic resonance imaging (MRI) [ Time Frame: 30 minutes ]Gastric accommodation and sensitivity change between active and inactive auricular tVNS
- Electrogastrography (EGG) [ Time Frame: 2 hours ]We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
- Electrocardiography (ECG) [ Time Frame: 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 [ Time Frame: 2 hours ]Respiration will be measured in beats per minute (bpm).
- Skin Conductance Levels (SCL) [ Time Frame: 2 hours ]SCL will be measured in volts per second.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200889
|Contact: Rowan Staley, B.A.||firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Harrison Fisher email@example.com|
|Principal Investigator: Vitaly Napadow, PhD|
|Principal Investigator:||Vitaly Napadow, PhD||Harvard University|