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- Klinische proef NCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
1 september 2026 bijgewerkt door: Virginia Commonwealth University
Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Amy Erickson
- Telefoonnummer: 804-828-9165
- E-mail: amy.erickson@vcuhealth.org
Studie Locaties
-
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Virginia
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Richmond, Virginia, Verenigde Staten, 23298
- Virginia Commonwealth University
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Contact:
- Amy Erickson
- Telefoonnummer: 804-828-9165
- E-mail: amy.erickson@vcuhealth.org
-
Hoofdonderzoeker:
- Ryan Cleary, MD
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Sham-vergelijker: Schijnvertoning
|
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.
|
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Experimenteel: Transcutane auriculaire vagale zenuwstimulatie (taVNS)
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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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
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Assess changes in serum inflammatory marker interleukin (IL-2)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
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Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
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Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
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Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Tijdsspanne: Baseline, 1 week, and 2 weeks following intervention
|
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
|
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Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Tijdsspanne: Baseline, and 2 weeks following intervention
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Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
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Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Tijdsspanne: Baseline, and 2 weeks following intervention
|
Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
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Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Tijdsspanne: Baseline, and 2 weeks following intervention
|
Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
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Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Tijdsspanne: Baseline, and 2 weeks following intervention
|
Percent change of BBB permeability
|
Baseline, and 2 weeks following intervention
|
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Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Tijdsspanne: Baseline, and 2 weeks following intervention
|
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
|
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Assess interval changes in cerebral edema on MRI after treatment
Tijdsspanne: Baseline, and 2 weeks following intervention
|
Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
|
Baseline, and 2 weeks following intervention
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ryan Cleary, MD, Virginia Commonwealth University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 november 2026
Primaire voltooiing (Geschat)
31 augustus 2029
Studie voltooiing (Geschat)
31 augustus 2029
Studieregistratiedata
Eerst ingediend
25 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
25 juni 2026
Eerst geplaatst (Werkelijk)
2 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MCC-25-22821
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .