- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
2026년 9월 1일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Amy Erickson
- 전화번호: 804-828-9165
- 이메일: amy.erickson@vcuhealth.org
연구 장소
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Virginia
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Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
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연락하다:
- Amy Erickson
- 전화번호: 804-828-9165
- 이메일: amy.erickson@vcuhealth.org
-
수석 연구원:
- Ryan Cleary, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: 가짜
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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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실험적: 경피적 귀 미주 신경 자극(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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
기간: 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
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Baseline, 1 week, and 2 weeks following intervention
|
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Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
기간: 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)
기간: 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)
기간: 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
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Baseline, 1 week, and 2 weeks following intervention
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Assess changes in serum inflammatory marker interleukin-10 (IL-10)
기간: 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)
기간: 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)
기간: 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)
기간: 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
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Baseline, 1 week, and 2 weeks following intervention
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Assess changes in serum inflammatory marker interleukin 4 (IL-4)
기간: 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
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Baseline, 1 week, and 2 weeks following intervention
|
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Assess changes in serum inflammatory marker interleukin 5 (IL-5)
기간: 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)
기간: 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
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Baseline, 1 week, and 2 weeks following intervention
|
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Assess changes in serum inflammatory marker interleukin 8 (IL-8)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, and 2 weeks following intervention
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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
기간: Baseline, and 2 weeks following intervention
|
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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ryan Cleary, MD, Virginia Commonwealth University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 30일
기본 완료 (추정된)
2029년 8월 31일
연구 완료 (추정된)
2029년 8월 31일
연구 등록 날짜
최초 제출
2026년 6월 25일
QC 기준을 충족하는 최초 제출
2026년 6월 25일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .