TENS of Auricular Vagal Nerve for Radiation Necrosis

NCT07680127 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MCC-25-22821
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Necrosis; Cerebral Edema

Keywords

Radiation Necrosis

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, 1 week, and 2 weeks following intervention

Secondary Outcomes (18)

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

  Baseline, 1 week, and 2 weeks following intervention

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

  Baseline, 1 week, and 2 weeks following intervention

• Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)

  Baseline, 1 week, and 2 weeks following intervention

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

  Baseline, 1 week, and 2 weeks following intervention

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

  Baseline, 1 week, and 2 weeks following intervention

Study Arms (2)

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

EXPERIMENTAL

Device: Transcutaneous auricular vagal nerve stimulation (taVNS)

Sham

SHAM COMPARATOR

Device: Sham

Interventions

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.

Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)

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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ryan Cleary, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Erickson

CONTACT

804-828-9165; amy.erickson@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

US (1)