Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07680127

TENS of Auricular Vagal Nerve for Radiation Necrosis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Radiation Necrosis Brain Diseases Brain Edema Central Nervous System Diseases Cerebral Edema Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location contact

Amy Erickson

CONTACT

[email protected]

804-828-9165

Ryan Cleary, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Transcutaneous auricular vagal nerve stimulation (taVNS)

Device

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

Device

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.

Primary outcomes

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

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples

Secondary outcomes

  1. Assess changes in serum inflammatory marker Interleukin 12 (IL-12)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in (IL-12) serum inflammatory marker utilizing serum inflammatory marker analysis from collected blood samples

  2. Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples

  3. Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IFN gamma utilizing serum inflammatory marker analysis from collected blood samples

  4. Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IL-1b utilizing serum inflammatory marker analysis from collected blood samples

  5. Assess changes in serum inflammatory marker interleukin-10 (IL-10)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IL-10 utilizing serum inflammatory marker analysis from collected blood samples

  6. Assess changes in serum inflammatory marker interleukin 13 (IL-13)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IL-13 utilizing serum inflammatory marker analysis from collected blood samples

  7. Assess changes in serum inflammatory marker interleukin (IL-2)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IL-2 utilizing serum inflammatory marker analysis from collected blood samples

  8. Assess changes in serum inflammatory markers interleukin 17 (IL-17A)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory markers IL-17A utilizing serum inflammatory marker analysis from collected blood samples

  9. Assess changes in serum inflammatory marker interleukin 4 (IL-4)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory marker IL-4 utilizing serum inflammatory marker analysis from collected blood samples

  10. Assess changes in serum inflammatory marker interleukin 5 (IL-5)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory markers IL-5 utilizing serum inflammatory marker analysis from collected blood samples

  11. Assess changes in serum inflammatory marker interleukin 6 (IL-6)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory markers IL-6 utilizing serum inflammatory marker analysis from collected blood samples

  12. Assess changes in serum inflammatory marker interleukin 8 (IL-8)

    Time frame: Baseline, 1 week, and 2 weeks following intervention

    Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples

  13. Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment

    Time frame: Baseline, and 2 weeks following intervention

    Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples

  14. Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment

    Time frame: Baseline, and 2 weeks following intervention

    Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples

  15. Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment

    Time frame: Baseline, and 2 weeks following intervention

    Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples

  16. Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment

    Time frame: Baseline, and 2 weeks following intervention

    Percent change of BBB permeability

  17. Assess interval changes in radiation necrosis on MRI after treatment w taVNS

    Time frame: Baseline, and 2 weeks following intervention

    Percent changes in areas of contrast enhancement and perilesional T2-weighted fluid-attenuated inversion recovery (T2/FLAIR) Hypersensitivity on magnetic resonance imaging (MRI). On these images, areas with higher water content suck as edema, inflammation, or demyelination, appear brighter compared to surrounding tissue.

  18. Assess interval changes in cerebral edema on MRI after treatment

    Time frame: Baseline, and 2 weeks following intervention

    Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Erickson

CONTACT

[email protected]

804-828-9165

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.