[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07680127":3,"trial-entities:NCT07680127":146,"trial-summary:NCT07680127":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":101,"minimum_age":102,"maximum_age":17,"healthy_volunteers":103,"eligibility_criteria":104,"std_ages":119,"locations":122,"central_contacts":140,"overall_officials":142,"references":144,"see_also_links":145},"NCT07680127","MCC-25-22821","TENS of Auricular Vagal Nerve for Radiation Necrosis","Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis","NOT_YET_RECRUITING","2029-08-31","2026-06","2026-07-02","2026-07-31","Virginia Commonwealth University","OTHER",true,"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.",null,[19,20],"Radiation Necrosis","Cerebral Edema",[19],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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.",[35],"Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)",{"type":31,"name":37,"description":38,"armGroupLabels":39},"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.",[37],[41],{"measure":42,"description":43,"timeFrame":44},"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",[46,49,52,55,58,61,64,67,70,73,76,79,82,86,89,92,95,98],{"measure":47,"description":48,"timeFrame":44},"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",{"measure":50,"description":51,"timeFrame":44},"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",{"measure":53,"description":54,"timeFrame":44},"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",{"measure":56,"description":57,"timeFrame":44},"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",{"measure":59,"description":60,"timeFrame":44},"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",{"measure":62,"description":63,"timeFrame":44},"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",{"measure":65,"description":66,"timeFrame":44},"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",{"measure":68,"description":69,"timeFrame":44},"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",{"measure":71,"description":72,"timeFrame":44},"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",{"measure":74,"description":75,"timeFrame":44},"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",{"measure":77,"description":78,"timeFrame":44},"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",{"measure":80,"description":81,"timeFrame":44},"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",{"measure":83,"description":84,"timeFrame":85},"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",{"measure":87,"description":88,"timeFrame":85},"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",{"measure":90,"description":91,"timeFrame":85},"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",{"measure":93,"description":94,"timeFrame":85},"Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment","Percent change of BBB permeability",{"measure":96,"description":97,"timeFrame":85},"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\u002FFLAIR) 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.",{"measure":99,"description":100,"timeFrame":85},"Assess interval changes in cerebral edema on MRI after treatment","Percent changes in areas of contrast enhancement and perilesional T2\u002FFLAIR Hypersensitivity on MRI","ALL","18 Years",false,{"inclusion":105,"exclusion":111,"raw_text":118},[106,107,108,109,110],"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.",[112,113,114,115,116,117],"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 \\\u003C 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\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.","Inclusion Criteria:\n\n* History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy\n* Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment.\n* Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion\n* At least 18 years of age\n* 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.\n\nExclusion Criteria:\n\n* New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment\n* Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab \\\u003C 6 weeks prior to study enrollment.\n* 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.\n* History of cardiac conduction disorders or presence of implanted electronic devices\n* Active Crohn's disease or other inflammatory bowel disease.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.",[120,121],"ADULT","OLDER_ADULT",[123],{"facility":13,"city":124,"state":125,"zip":126,"country":127,"contacts":128,"geoPoint":137},"Richmond","Virginia","23298","United States",[129,134],{"name":130,"role":131,"phone":132,"email":133},"Amy Erickson","CONTACT","804-828-9165","amy.erickson@vcuhealth.org",{"name":135,"role":136},"Ryan Cleary, MD","PRINCIPAL_INVESTIGATOR",{"lat":138,"lon":139},37.55376,-77.46026,[141],{"name":130,"role":131,"phone":132,"email":133},[143],{"name":135,"affiliation":13,"role":136},[],[],{"nct_id":4,"conditions":147,"biomarkers":148},[20,19],[],{"nct_id":4,"found":15,"summary":150,"prompt_version":159},{"design":151,"status":152,"heading":6,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is a multi-center, randomized, and blinded study, meaning participants are randomly assigned to either the treatment or sham group, and neither you nor your doctors will know which group you are in. It plans to enroll 40 participants.","completed","This study is looking at whether a device called transcutaneous auricular vagal nerve stimulation (taVNS) can help with radiation necrosis (damage to brain tissue after radiation treatment) and cerebral edema (swelling in the brain). You might be able to join if you are 18 or older, have a history of brain cancer or lesions treated with radiation, and have MRI scans that suggest radiation necrosis. The study will compare taVNS to a sham device (which looks like the real device but doesn't deliver stimulation). Researchers will measure a marker of inflammation called Tumor Necrosis Factor (TNF)-alpha in your blood to see if the treatment is successful. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","Changes in inflammatory markers will be assessed at baseline, 1 week, and 2 weeks following the intervention.",121,"You would receive either active or sham stimulation twice daily for 12 to 14 days. You would also have imaging, tissue, and blood collected for assessment.","Not stated in the trial record.",[32,37],"v2"]