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

NCT ID: NCT06557720

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-11

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug Resistant Epilepsy Magnetic Resonance Imaging Electroencephalogram (EEG)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intractable epilepsy patients.

Based on the hybrid fusion technology of PET-fMRI-EEG, this study explores the characteristics of brain network damage in refractory epilepsy, identifies key network nodes (such as central nodes), and provides more assistance for the diagnosis of drug-resistant epilepsy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. In a state of continuous epileptic seizures;
2. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiang Wen

Role: STUDY_CHAIR

Xi Jing hospital

Locations

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Xijing Hospital of Air Force Military Medical University

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guan Xiao

Role: CONTACT

18392320919

Facility Contacts

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guan xiao, master

Role: primary

18392320919

References

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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.

Reference Type BACKGROUND
PMID: 15804240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17054693 (View on PubMed)

Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

Reference Type BACKGROUND
PMID: 10660394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33597576 (View on PubMed)

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. Epub 2019 Jan 19.

Reference Type BACKGROUND
PMID: 30772238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25893383 (View on PubMed)

Other Identifiers

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KY20242168

Identifier Type: -

Identifier Source: org_study_id

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