TENS of Auricular Vagal Nerve for Radiation Necrosis

Официальное название

Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]

Вторичные конечные точки (12)

• Assess changes in serum inflammatory marker Interleukin 12 (IL-12) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker Interferon gamma (IFN gamma) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin-10 (IL-10) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 13 (IL-13) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin (IL-2) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory markers interleukin 17 (IL-17A) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 4 (IL-4) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 5 (IL-5) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 6 (IL-6) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]
• Assess changes in serum inflammatory marker interleukin 8 (IL-8) [Срок оценки: Baseline, 1 week, and 2 weeks following intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT07680127 · MCC-25-22821

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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