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NOT YET RECRUITING
NCT07680127
NA

TENS of Auricular Vagal Nerve for Radiation Necrosis

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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