Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-29 @ 11:05 PM
Study NCT ID:
NCT06518356
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2024-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mastoid taVNS-fMRI
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: