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Not yet recruiting NCT07680127

TENS of Auricular Vagal Nerve for Radiation Necrosis

No phase Interventional Radiation Necrosis Cerebral Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous auricular vagal nerve stimulation (taVNS), Sham.
Who it may be relevant to
Registry conditions: Radiation Necrosis, Cerebral Edema. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis

Overview

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.

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.

Primary outcome measures

  • Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha [Time frame: Baseline, 1 week, and 2 weeks following intervention]
Secondary outcome measures (12)
  • Assess changes in serum inflammatory marker Interleukin 12 (IL-12) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker Interferon gamma (IFN gamma) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin-10 (IL-10) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 13 (IL-13) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin (IL-2) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory markers interleukin 17 (IL-17A) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 4 (IL-4) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 5 (IL-5) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 6 (IL-6) [Time frame: Baseline, 1 week, and 2 weeks following intervention]
  • Assess changes in serum inflammatory marker interleukin 8 (IL-8) [Time frame: Baseline, 1 week, and 2 weeks following intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07680127 · MCC-25-22821

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗