Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

NCT ID: NCT06524479

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2027-10-08

Brief Summary

This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.

Detailed Description

Sleep serves as a fundamental physiological state whose disruption has profound implications for neurological health. The daily alternation between sleep and wakefulness reflects an intrinsic circadian rhythm that orchestrates critical fluctuations in cortical excitability and functional connectivity throughout the brain. The cerebral cortex, comprising approximately 80% of total brain volume, forms the neural substrate for higher-order cognitive functions including sensory perception, executive control, and memory processes. Importantly, sleep acts as a global brain modulator that dynamically reorganizes patterns of neural communication across distributed cortical and subcortical networks.

Stereoelectroencephalography (SEEG) provides direct access to intracranial electrophysiological activity with exceptional spatiotemporal resolution. When combined with single-pulse electrical stimulation (SPES), this powerful methodology enables quantitative assessment of inter-regional connectivity through analysis of evoked potentials, allowing precise characterization of both connection strength and directionality. This integrated approach offers unique opportunities to examine how different vigilance states modulate cortical excitability and reorganize functional brain networks, particularly in clinical populations with neurological disorders. The ability to track state-dependent changes in network dynamics provides crucial insights into both normal brain function and pathological conditions.

Conditions

Refractory Epilepsy; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SEEG recordings and SPES effects

Single-pulse electrical stimulation (SPES) evokes transient neuronal responses that propagate through functional networks, providing a powerful tool to map brain connectivity. When delivered at low frequencies (0.05 Hz, every 20 s), SPES allows quantitative assessment of dynamic network interactions while avoiding long-term synaptic modifications. These stimulation-induced responses, recorded via stereoelectroencephalography (SEEG), reveal both local and distributed neural activity with millisecond precision.

Group Type: EXPERIMENTAL

SEEG recordings and SPES

Intervention Type: PROCEDURE

This study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics.

Interventions

SEEG recordings and SPES

This study will utilize stereoelectroencephalography (SEEG) recordings combined with single-pulse electrical stimulation (SPES) to investigate functional brain connectivity and cortical excitability patterns in patients with epilepsy during both wakefulness and sleep states. The SEEG recordings will provide high-resolution intracranial electrophysiological data, while SPES will be employed to actively probe and quantify cortico-cortical connections. This combined approach will enable characterization of state-dependent neural network dynamics.

Intervention Type: PROCEDURE

Eligibility Criteria

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)
• Subjects that experience surgical complications during the implant procedure will be excluded from the study

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Liankun_Ren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liankun Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liankun Ren, MD

Role: CONTACT

renlk2022@outlook.com

13681576621

Facility Contacts

Liankun Ren, MD

Role: primary

renlk2022@outlook.com

+86 13681576621

Other Identifiers

2024-208-002

Identifier Type: -

Identifier Source: org_study_id