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TENS of Auricular Vagal Nerve for Radiation Necrosis
Sponsor: Virginia Commonwealth University
Summary
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema. In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2). Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.
Official title: Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-07-31
Completion Date
2029-08-31
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous auricular vagal nerve stimulation (taVNS)
Transcutaneous auricular vagal nerve stimulation (taVNS) stimulation twice daily for 12 to 14 days prior to planned LITT ablation via TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear.
Sham
TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear, with no stimulation twice daily for 12 to 14 days prior to planned LITT ablation.
Locations (1)
Virginia Commonwealth University
Richmond, Virginia, United States