The Role of Intracranial Electroencephalography (IEEG) in the Localization of Epileptogenic Zones (EZ) and Its Relationship With Prognosis

Epilepsy Clinical Trial

Official title:

The Role of IEEG in the Localization of EZ and Its Relationship With Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443958
• Other study ID #: 2020-910
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Lingli Hu, Master
• Phone: 18613040114
• Email: hulingli21[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. For focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. Accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. Intracranial EEG (iEEG) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. It can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of EEG during interictal and ictal periods. The in-depth analysis of iEEG can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Complete clinical history;

2. IEEG monitoring at least one habitual seizure;

3. Follow up for at least 1 year;

4. Signed informed consent.

Exclusion Criteria:

1. Habitual seizures were not found in iEEG monitoring;

2. No operation was performed;

3. Lost to follow-up for various reasons within 1 year after surgery.

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups	Compare two groups of patients with clinical data (sex, age at onset, age at surgery, epilepsy duration, seizure lateralization/localization, MRI findings, Pathology) and EEG characteristics (contact number, EEG onset pattern, IEEG power of each frequency band, functional connectivity of each frequency band).	1-2 years