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

Recruiting

• Conditions: Magnetic Resonance Imaging; Electroencephalogram (EEG); Drug Resistant Epilepsy

• Registration Number: NCT06557720
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-11
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-06-11
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The characteristics of hybrid imaging in patients with different types of refractory epilepsy.	baseline	Based on PET-FMRI-EEG hybrid fusion technology, explore the brain network characteristics of epilepsy patients.PET detects areas of reduced glucose metabolism, using radioactive isotopes (such as 18F-labeled fluorodeoxyglucose) to reflect the glucose metabolism of brain tissue. Typically in epilepsy patients, areas of hypometabolism may indicate the presence of epileptic foci. By using fMRI or EEG data, the synchronization of activities between different brain regions is analyzed to understand the organization and functional connectivity patterns of the brain network.
The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy.	baseline	Using different data analysis methods to explore the characteristics of PET, fMRI, and EEG indicators in patients with various types of intractable epilepsy.The characteristics of the power spectrum of various EEG frequency bands (Delta, Theta, Alpha, Beta, Gamma waves) and brain functional connectivity.

Secondary Outcome Measures

Name	Time	Method
Quality of Life in Epilepsy 31 (QOLIE-31)	baseline，4weeks	It assesses various aspects of a patient's life that can be affected by their condition, including physical, emotional, and social well-being.

Trial Locations

Locations (1)

Xijing Hospital of Air Force Military Medical University; 🇨🇳 Xi'an, China