Clinical trial NCT06557720: Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Based on Multimodal Imaging Technology
Official title: Exploring the Characteristics of Epileptogenic Foci in Drug-Resistant Epilepsy Using Multimodal Imaging Techniques: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Resistant Epilepsy
Magnetic Resonance Imaging
Electroencephalogram (EEG)
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: drug-resistant epilepsy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The characteristics of hybrid imaging in patients with different types of refractory epilepsy.
timeFrame: baseline
measure: The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy.
timeFrame: baseline
Secondary outcomes:
measure: Quality of Life in Epilepsy 31 (QOLIE-31)
timeFrame: baseline，4weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Military Medical University
Study officials:
affiliation: Xi Jing hospital
name: Jiang Wen
role: STUDY_CHAIR
References:
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