High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT (Epi-PRECISE)
2026年8月12日 更新者：Kai Zhang、Beijing Tiantan Hospital
Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
調査の概要
状態
募集
詳細な説明
- Compare the effect of intraoperative high-density flexible μECoG guidance versus no intraoperative μECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
- Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
研究の種類
介入
入学 (推定)
85
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：Kai Zhang Dr
- 電話番号：86 01059975051
- メール：zhangkai62035@sina.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100070
- 募集
- Beijing Tiantan Hospital
-
コンタクト：
- Du Cai Dr
- 電話番号：86 01059975051
- メール：ferryc22@163.com
-
-
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
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 3 to 60 years.
- Diagnosis of drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed and adequately tried antiseizure medications.
- Diagnosis of focal epilepsy after standard presurgical evaluation and considered suitable for resective epilepsy surgery.
- Preoperative cognitive or developmental status sufficient to participate in study assessments, as judged by the investigator and assessed using age-appropriate validated instruments. For participants aged 3 to 6 years, developmental status must be within the normal range according to the Griffiths Mental Development Scales. For participants aged 6 to 16 years, cognitive function must be within the normal range according to the Wechsler Intelligence Scale for Children. For participants older than 16 years, a Mini-Mental State Examination score of 24 or higher will be required.
- Written informed consent provided by the participant or, when applicable, by a legal guardian.
Exclusion Criteria:
- Suspected mesial temporal lobe epilepsy after multidisciplinary presurgical evaluation.
- History of any previous neurosurgical craniotomy before epilepsy surgery.
- Severe psychiatric, cognitive, or psychological disorder that prevents participation in the study or completion of follow-up.
- Contraindication to surgery.
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intraoperative application of high-density flexible μECoG-Guided Resection
|
During resective epilepsy surgery, a sterile high-density flexible microelectrocorticography will be placed on the exposed cortical surface over the suspected epileptogenic zone and adjacent cortex.
The array will be used for high-spatial-resolution intraoperative μECoG recording and real-time analysis of epileptiform activity, including interictal spikes, high-frequency oscillations, spatial discharge gradients, and propagation patterns.
The intraoperative ECoG findings will be provided to the surgical team to assist in defining the epileptogenic zone and tailoring the extent of resection.
The high-density μECoG is used for intraoperative recording only and will be removed before wound closure.
|
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 |
|---|---|---|
|
Seizure Freedom Rate at 6 Months After Surgery
時間枠：From surgery to 6 months postoperatively
|
The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
|
From surgery to 6 months postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seizure Freedom Rate at 1 Year After Surgery
時間枠：From surgery to 1 year postoperatively
|
The proportion of participants who remain free from any type of epileptic seizure during the 1-year postoperative follow-up period.
|
From surgery to 1 year postoperatively
|
|
Postoperative Seizure Outcome According to ILAE Classification
時間枠：6 months and 1 year postoperatively
|
Postoperative seizure outcome will be evaluated using the International League Against Epilepsy classification at 6 months and 1 year after surgery.
ILAE class 1 indicates complete seizure freedom without aura, and higher classes indicate worse seizure outcomes.
|
6 months and 1 year postoperatively
|
|
Monthly Seizure Frequency
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
Monthly seizure frequency will be assessed before surgery and at 6 months and 1 year after surgery.
The measure is defined as the average number of epileptic seizures per month.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
|
Postoperative Complications
時間枠：Perioperative period, 6 months postoperatively, and 1 year postoperatively
|
The incidence of postoperative complications, including infection, fever, neurological deficits, and other surgery-related complications, will be recorded during the perioperative period and postoperative follow-up.
|
Perioperative period, 6 months postoperatively, and 1 year postoperatively
|
|
Surgery-Related Adverse Events
時間枠：Perioperative period
|
The incidence of surgery-related adverse events will be recorded during the perioperative period.
Adverse events include events directly related to the surgical procedure.
|
Perioperative period
|
|
Serious Adverse Events
時間枠：Perioperative period
|
The incidence of serious adverse events, including postoperative death or severe deterioration of health status during the perioperative period, will be recorded.
|
Perioperative period
|
|
Seizure Severity Assessed by the National Hospital Seizure Severity Scale
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
Seizure severity will be assessed using the National Hospital Seizure Severity Scale (NHS3) before surgery and at 6 months and 1 year after surgery.
The NHS3 is a seizure severity scale with scores ranging from 1 to 27, with higher scores indicating more severe seizures and therefore a worse outcome.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
|
Developmental Function Assessed by the Griffiths Mental Development Scales
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
For participants aged 3 to 6 years, developmental function will be evaluated using the Griffiths Mental Development Scales before surgery and at 6 months and 1 year after surgery.
The primary reported score will be the General Developmental Quotient or General Quotient.
The quotient score ranges from 50 to 150, with higher scores indicating better developmental function and therefore a better outcome.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
|
Cognitive Function Assessed by the Wechsler Intelligence Scale for Children
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
For participants aged 6 to 16 years, cognitive function will be evaluated using the Wechsler Intelligence Scale for Children before surgery and at 6 months and 1 year after surgery.
The primary reported score will be the Full Scale Intelligence Quotient.
The Full Scale Intelligence Quotient standard score ranges from 40 to 160, with higher scores indicating better cognitive function and therefore a better outcome.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
|
Cognitive Function Assessed by the Mini-Mental State Examination
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
For participants older than 16 years, cognitive function will be evaluated using the Mini-Mental State Examination (MMSE) before surgery and at 6 months and 1 year after surgery.
The MMSE total score ranges from 0 to 30, with higher scores indicating better cognitive function and therefore a better outcome.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
|
Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0
時間枠：Baseline, 6 months postoperatively, and 1 year postoperatively
|
Quality of life will be evaluated before surgery and at 6 months and 1 year after surgery.
Adult participants will be assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and pediatric participants will be assessed using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).
Both scales are transformed to scores ranging from 0 to 100, with higher scores indicating better quality of life and therefore a better outcome.
|
Baseline, 6 months postoperatively, and 1 year postoperatively
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Guo J, Wang Z, van 't Klooster MA, Van Der Salm SM, Leijten FS, Braun KP, Zijlmans M. Seizure Outcome After Intraoperative Electrocorticography-Tailored Epilepsy Surgery: A Systematic Review and Meta-Analysis. Neurology. 2024 Jun 11;102(11):e209430. doi: 10.1212/WNL.0000000000209430. Epub 2024 May 20.
- Xingjian Liu, Chao Zhang, Baotian Zhao, et al., Preliminary application study of flexible high-density cortical electrodes in assisting localization of epileptogenic zones during epileptogenic zonectomy, Chinese Journal of Neurosurgery, 2025, 41(12):1237-1244. DOI:10.3760/cma.j.cn112050-20250919-00362
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9月1日
一次修了 (推定)
2028年7月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月12日
最終確認日
2026年6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。