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

June 23, 2025 updated by: Xijing Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • Xijing Hospital of Air Force Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

drug-resistant epilepsy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The characteristics of hybrid imaging in patients with different types of refractory epilepsy.
Time Frame: 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.
baseline
The characteristics of PET, fMRI, and EEG indicators in patients with different types of intractable epilepsy.
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life in Epilepsy 31 (QOLIE-31)
Time Frame: 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.
baseline，4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Jiang Wen, Xi Jing hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

June 11, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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