NCT07680127尚未招募不适用
Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Sham
Sham Comparator
干预措施: Sham (Device)
Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)
Experimental
干预措施: Transcutaneous auricular vagal nerve stimulation (taVNS) (Device)
结局指标
主要结局
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
时间窗: 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
次要结局
- Assess changes in serum inflammatory marker Interleukin 12 (IL-12)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin-10 (IL-10)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 13 (IL-13)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin (IL-2)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory markers interleukin 17 (IL-17A)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 4 (IL-4)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 5 (IL-5)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 6 (IL-6)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in serum inflammatory marker interleukin 8 (IL-8)(Baseline, 1 week, and 2 weeks following intervention)
- Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment(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(Baseline, and 2 weeks following intervention)
- Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment(Baseline, and 2 weeks following intervention)
- Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment(Baseline, and 2 weeks following intervention)
- Assess interval changes in radiation necrosis on MRI after treatment w taVNS(Baseline, and 2 weeks following intervention)
- Assess interval changes in cerebral edema on MRI after treatment(Baseline, and 2 weeks following intervention)
研究者
研究点 (1)
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