Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG

Not Applicable

Recruiting

• Conditions: Epilepsy

• Registration Number: NCT06667232
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.

Detailed Description

Our research group plans to conduct a study on patients with drug-resistant epilepsy who have SEEG electrodes implanted. The study will evaluate and compare the modulation effect of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation via direct electrical stimulation using SEEG. The goal is to explore the focal and network modulation effect of distinct stimulation paradigms during the resting state and post-seizure state.

Study Timeline

• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-31
• Status Verified: 2025-01
• Study Start: 2025-01-18
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12-25
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Drug-resistant focal epilepsy
• Justified SEEG exploration in the context of presurgical assessment of epilepsy
• Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis
• Written non-opposition to study participation

Exclusion Criteria

• Pregnant women (Contraindication to SEEG exploration)
• Psychiatric disorders
• History of psychotic disorders
• History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
• Subjects that experience surgical complications during the implant procedure will be excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modulation Factor	During the trial(up to 3 hours for each subject)	Investigators calculate normalized the Modulation Factors of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation patterns using (stimulation-pre-stimulation)/(stimulation + pre-stimulation)
EEG power in spectral frequency bands	During the trial(up to 3 hours for each subject)	Using SEEG-implanted electrodes, the investigators applied electrical stimulation single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods.; EEG Frequency Bands delta (1-4 Hz) theta (5-8 Hz) alpha (9-12 Hz) beta (13-30 Hz) low gamma (31-70 Hz) high gamma (71-150 Hz)
Phase Locking Value	During the trial(up to 3 hours for each subject)	To estimate functional connectivity through the oscillatory synchrony of two brain regions, phase locking value (PLV) provides a measure of inter-regional synchrony based on phase difference between the paired signals.

Trial Locations

Locations (1)

Xuanwu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China