An interventional study of Transcutaneous auricular vagal nerve stimulation (taVNS) and Sham in Radiation Necrosis and Cerebral Edema, sponsored by Virginia Commonwealth University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
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.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 62 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Transcutaneous auricular vagal nerve stimulation (taVNS)
Device: Sham
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.
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.
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
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Percent change in (IL-12) serum inflammatory marker utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Percent change in serum inflammatory marker IFN gamma utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Percent change in serum inflammatory marker IL-1b utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Percent change in serum inflammatory marker IL-10 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Percent change in serum inflammatory marker IL-13 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin (IL-2)
Percent change in serum inflammatory marker IL-2 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Percent change in serum inflammatory markers IL-17A utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Percent change in serum inflammatory marker IL-4 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Percent change in serum inflammatory markers IL-5 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Percent change in serum inflammatory markers IL-6 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, 1 week, and 2 weeks following intervention
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
Time frame: Baseline, and 2 weeks following intervention
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Percent change of BBB permeability
Time frame: Baseline, and 2 weeks following intervention
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
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.
Time frame: Baseline, and 2 weeks following intervention
Assess interval changes in cerebral edema on MRI after treatment
Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
Time frame: Baseline, and 2 weeks following intervention
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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