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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Amy Erickson
- 電話番号：804-828-9165
- メール：amy.erickson@vcuhealth.org
研究場所
-
-
Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
-
コンタクト：
- Amy Erickson
- 電話番号：804-828-9165
- メール：amy.erickson@vcuhealth.org
-
主任研究者：
- Ryan Cleary, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：シャム
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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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実験的：経皮的耳介迷走神経刺激 (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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
時間枠：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
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Baseline, 1 week, and 2 weeks following intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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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)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory marker GMCSF 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 Interferon gamma (IFN gamma)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory marker IFN gamma 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 1 beta (IL-1b)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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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)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory marker IL-10 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 13 (IL-13)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory marker IL-13 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 (IL-2)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory marker IL-2 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 markers interleukin 17 (IL-17A)
時間枠：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)
時間枠：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
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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)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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Percent change in serum inflammatory markers IL-5 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 6 (IL-6)
時間枠：Baseline, 1 week, and 2 weeks following intervention
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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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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Baseline, and 2 weeks following intervention
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Assess interval changes in cerebral edema on MRI after treatment
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ryan Cleary, MD、Virginia Commonwealth University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月30日
一次修了 (推定)
2029年8月31日
研究の完了 (推定)
2029年8月31日
試験登録日
最初に提出
2026年6月25日
QC基準を満たした最初の提出物
2026年6月25日
最初の投稿 (実際)
2026年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。