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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 1 week, and 2 weeks following intervention |
| Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Erickson | Contact | 804-828-9165 | amy.erickson@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Cleary, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D001929 | Brain Edema |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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. |
|
Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, and 2 weeks following intervention |
| Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment | Percent change of BBB permeability | 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. | 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 | Baseline, and 2 weeks following intervention |