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Clinical Trials/NCT06518356
NCT06518356
Completed
N/A

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

Medical University of South Carolina1 site in 1 country24 target enrollmentAugust 26, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Auricular Stimulation
Sponsor
Medical University of South Carolina
Enrollment
24
Locations
1
Primary Endpoint
Blood oxygen level-dependent (BOLD) signal changes during stimulation relative to sham stimulation
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. Investigators will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2024
End Date
April 28, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaolong Peng

Research Instructor-Faculty

Medical University of South Carolina

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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