- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
1 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Amy Erickson
- Número de teléfono: 804-828-9165
- Correo electrónico: amy.erickson@vcuhealth.org
Ubicaciones de estudio
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Contacto:
- Amy Erickson
- Número de teléfono: 804-828-9165
- Correo electrónico: amy.erickson@vcuhealth.org
-
Investigador principal:
- Ryan Cleary, MD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: Impostor
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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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Experimental: Estimulación transcutánea del nervio vagal auricular (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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Periodo de tiempo: Baseline, 1 week, and 2 weeks following intervention
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Periodo de tiempo: Baseline, 1 week, and 2 weeks following intervention
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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)
Periodo de tiempo: Baseline, 1 week, and 2 weeks following intervention
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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)
Periodo de tiempo: 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
|
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Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples
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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
Periodo de tiempo: 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
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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
Periodo de tiempo: Baseline, and 2 weeks following intervention
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Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
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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
Periodo de tiempo: Baseline, and 2 weeks following intervention
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Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
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Baseline, and 2 weeks following intervention
|
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Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Periodo de tiempo: Baseline, and 2 weeks following intervention
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Percent change of BBB permeability
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Baseline, and 2 weeks following intervention
|
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Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Periodo de tiempo: 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.
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Baseline, and 2 weeks following intervention
|
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Assess interval changes in cerebral edema on MRI after treatment
Periodo de tiempo: Baseline, and 2 weeks following intervention
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Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
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Baseline, and 2 weeks following intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ryan Cleary, MD, Virginia Commonwealth University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de noviembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2029
Finalización del estudio (Estimado)
31 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
2 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCC-25-22821
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .