Mastoid taVNS-fMRI
Investigating the Direct Brain Effects of Activating the Auricular Branch of the Vagus Nerve From the Cymba Concha or Mastoid Process: a Sham-controlled fMRI Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that delivers electric stimulation to the auricular branch of the vagus nerve (ABVN). This technique has been demonstrated effective in the treatment of depression and addiction in previous studies.
Most previous applications of taVNS targeted the ABVN via the cymba conchae or tragus sites. The mastoid process (mastoid site) is an important dermatome innervated by the ABVN, but there is currently a lack of knowledge on how taVNS on the mastoid site affects brain activity and whether it differs from the effect of stimulating the cymba site.
In this proposed study, the investigators plan to explore whether delivering taVNS to the mastoid site and the cymba site can induce different patterns of brain activity. Ultimately, if successful, this project will not only deepen our knowledge in basic neuroscience but also have great value in clinical applications since the mastoid site is a much more accessible ABVN target compared to other sites.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina Institute of Psychiatry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
Exclusion Criteria:
- Unable to speak in English.
- Contraindicated for MRI.
- Any current or recent untreated medical, neurological, or psychiatric conditions
- Metal implant devices in the head, heart or neck.
- History of brain surgery.
- History of myocardial infarction or arrhythmia, bradycardia.
- Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
- Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
- Participant has abnormal ear anatomy, skin irritation, or ear infection present
- Individuals suffering from frequent/severe headaches.
- Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
- Moderate to severe alcohol or substance use disorder.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Auricular Neurostimulation (Sham 1)
•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Sham (15Hz stimulation of the earlobe) |
The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN).
tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe).
|
|
Active Comparator: Auricular Neurostimulation (Active 1)
•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Cymba stimulation (15Hz stimulation of cymba conchae) |
The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN).
tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe).
|
|
Active Comparator: Auricular Neurostimulation (Active 2)
•Within the MRI scanner, each participant will be connected to a series of tAN electrodes that stimulate the following ear target -Mastoid stimulation (15Hz stimulation of mastoid process) |
The intervention the investigators are studying is called transcutaneous auricular neurostimulation (tAN).
tAN is simply electrical nerve stimulation administered at the ear which targets the auricular branch of the vagus nerve (ABVN) at the cymba conchae and mastoid process, and to a sham site (earlobe).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation
Time Frame: 30 minutes
|
taVNS will be administered to participants within the bore of the MRI scanner while the investigators acquire high-resolution functional neuroimaging.
Both a general linear model and SNM approach will be used to examine BOLD signal changes during stimulation relative to rest blocks, comparing each of the 3 stimulation targets within- and between- subjects to identify any differences in brain activity during stimulation of the mastoid site compared to the cymba site and sham site.
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xiaolong Peng, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00137424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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