Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Based on Multimodal Imaging Technology

Официальное название

Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Using Multimodal Imaging Techniques: A Prospective Observational Cohort Study

Обзор

Using multimodal imaging technology, this study aims to explore the characteristics of epileptogenic foci in patients with drug-resistant epilepsy and identify key network nodes (such as central nodes) to provide more assistance for the diagnosis of drug-resistant epilepsy.

Подробное описание

This study is a prospective observational cohort study. It prospectively recruited 50 patients with drug-resistant epilepsy from the Epilepsy Center of the Department of Neurology at Xijing Hospital, all aged 18 years or older. It collected general information and clinical baseline data such as magnetic resonance imaging; gathered multimodal imaging data once; analyzed the characteristics of epileptogenic foci in patients with drug-resistant epilepsy; and performed statistical analysis.

Первичные конечные точки

• The characteristics of hybrid imaging in patients with different types of refractory epilepsy. [Срок оценки: baseline]
• The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy. [Срок оценки: baseline]

Вторичные конечные точки (1)

• Quality of Life in Epilepsy 31 (QOLIE-31) [Срок оценки: baseline，4weeks]

Критерии участия

Критерии включения

• Aged ≥18 years old;
• Meet the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
• Duration of epilepsy ≥2 years, with an average seizure frequency of ≥2 times per month in the 3 months prior to enrollment;
• Adequate intake of two or more anti-epileptic drugs, with no intervention in the treatment plan during the trial period;
• Capable of cooperating to complete treatment and related examination items; The patient and family fully understand and voluntarily sign the informed consent form.

Критерии исключения

• In a state of continuous epileptic seizures;
• Complicated with severe infections, cerebrovascular diseases, malignant tumors, and other diseases, accompanied by severe dysfunction of the heart, liver, kidney, or other organs, or with mental disorders, or with uncorrectable hyperglycemia, or 3.patients on long-term use of corticosteroid medications;

4.Pregnant or lactating women; 5.Contraindications for PET, MR, EEG examinations; 6.Patients with examinations (with ferromagnetic metal implants in the body; high fever); 7.Participating in other clinical trials at the same time; 8.The patient or family withdraws the informed consent form.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Xijing Hospital of Air Force Military Medical University — Сиань

Публикации

• Theodore WH, Spencer SS, Wiebe S, Langfitt JT, Ali A, Shafer PO, Berg AT, Vickrey BG. Epilepsy in North America: a report prepared under the auspices of the global campaign against epilepsy, the International Bureau for Epilepsy, the International League Against Epilepsy, and the World Health Organization. Epilepsia. 2006 Oct;47(10):1700-22. doi: 10.1111/j.1528-1167.2006.00633.x. PMID 17054693
• Forsgren L, Beghi E, Oun A, Sillanpaa M. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005 Apr;12(4):245-53. doi: 10.1111/j.1468-1331.2004.00992.x. PMID 15804240
• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503. PMID 10660394
• Pinti P, Siddiqui MF, Levy AD, Jones EJH, Tachtsidis I. An analysis framework for the integration of broadband NIRS and EEG to assess neurovascular and neurometabolic coupling. Sci Rep. 2021 Feb 17;11(1):3977. doi: 10.1038/s41598-021-83420-9. PMID 33597576
• Tremblay S, Rogasch NC, Premoli I, Blumberger DM, Casarotto S, Chen R, Di Lazzaro V, Farzan F, Ferrarelli F, Fitzgerald PB, Hui J, Ilmoniemi RJ, Kimiskidis VK, Kugiumtzis D, Lioumis P, Pascual-Leone A, Pellicciari MC, Rajji T, Thut G, Zomorrodi R, Ziemann U, Daskalakis ZJ. Clinical utility and prospective of TMS-EEG. Clin Neurophysiol. 2019 May;130(5):802-844. doi: 10.1016/j.clinph.2019.01.001. Ep PMID 30772238
• Grouiller F, Delattre BM, Pittau F, Heinzer S, Lazeyras F, Spinelli L, Iannotti GR, Seeck M, Ratib O, Vargas MI, Garibotto V, Vulliemoz S. All-in-one interictal presurgical imaging in patients with epilepsy: single-session EEG/PET/(f)MRI. Eur J Nucl Med Mol Imaging. 2015 Jun;42(7):1133-43. doi: 10.1007/s00259-015-3045-2. Epub 2015 Apr 17. PMID 25893383

Идентификаторы

NCT: NCT06557720 · KY20242168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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