TENS of Auricular Vagal Nerve for Radiation Necrosis

This study is looking at whether a device called transcutaneous auricular vagal nerve stimulation (taVNS) can help with radiation necrosis (damage to brain tissue after radiation treatment) and cerebral edema (swelling in the brain). You might be able to join if you are 18 or older, have a history of brain cancer or lesions treated with radiation, and have MRI scans that suggest radiation necrosis. The study will compare taVNS to a sham device (which looks like the real device but doesn't deliver stimulation). Researchers will measure a marker of inflammation called Tumor Necrosis Factor (TNF)-alpha in your blood to see if the treatment is successful. The study is currently unclear on its recruitment status and plans to enroll 40 participants.

Study design: This is a multi-center, randomized, and blinded study, meaning participants are randomly assigned to either the treatment or sham group, and neither you nor your doctors will know which group you are in. It plans to enroll 40 participants.
What's involved: You would receive either active or sham stimulation twice daily for 12 to 14 days. You would also have imaging, tissue, and blood collected for assessment.
Compensation: Not stated in the trial record.
Follow-up: Changes in inflammatory markers will be assessed at baseline, 1 week, and 2 weeks following the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

TENS of Auricular Vagal Nerve for Radiation Necrosis

Not Yet Recruiting

NAAges 18+InterventionalSupportive care

Virginia Commonwealth University

~40 participants

Updated 2026-07-02 on ClinicalTrials.gov

What's tested:Transcutaneous auricular vagal nerve stimulation (taVNS)Sham

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha

Measured over Baseline, 1 week, and 2 weeks following intervention

Conditions

Radiation Necrosis

Cerebral Edema

Where it's being run

1 sites across 1 states

Virginia1

Study leadership

Ryan Cleary, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Amy Erickson

[email protected]

804-828-9165

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy

Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment.

Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion

At least 18 years of age

If on corticosteroids, able to discontinue at least 5 days prior to start of transcutaneous auricular vagus nerve stimulation (taVNS) (Arm 1) or sham treatment (Arm 2). A stable physiologic dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the investigator. 6. Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion

New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment

Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab \< 6 weeks prior to study enrollment.

Currently receiving any investigational agents for treatment of radiation necrosis or has participated in a study of an investigational agent for radiation necrosis within 3 weeks prior to study enrollment.

History of cardiac conduction disorders or presence of implanted electronic devices

Active Crohn's disease or other inflammatory bowel disease.

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

What this trial measures

Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alphaBaseline, 1 week, and 2 weeks following intervention
Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples

Trialytics