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TENS of Auricular Vagal Nerve for Radiation Necrosis

2026年9月1日 更新者: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.

研究概览

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University
        • 接触:
        • 首席研究员:
          • Ryan Cleary, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
假比较器:假
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.
实验性的:经皮耳迷走神经刺激 (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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
Assess changes in serum inflammatory marker interleukin (IL-2)
大体时间: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)
大体时间: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
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
大体时间: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
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
大体时间: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)
大体时间: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
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
大体时间: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
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
大体时间:Baseline, and 2 weeks following intervention
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
大体时间: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
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
大体时间: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
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
大体时间:Baseline, and 2 weeks following intervention
Percent change of BBB permeability
Baseline, and 2 weeks following intervention
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
大体时间: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
Assess interval changes in cerebral edema on MRI after treatment
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ryan Cleary, MD、Virginia Commonwealth University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月30日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2029年8月31日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MCC-25-22821

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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