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Recruiting NCT06524479

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

No phase Interventional Refractory Epilepsy Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEEG recordings and SPES.
Who it may be relevant to
Registry conditions: Refractory Epilepsy, Sleep. Basic parameters: 14 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure 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 characteriz

Primary outcome measures

  • SEEG recordings with SPES during daytime and sleeptime [Time frame: 48 hours]
Secondary outcome measures (6)
  • Dynamic melatonin levels [Time frame: 48 hours]
  • Dynamic cortisone levels [Time frame: 48 hours]
  • Dynamic 11-Deoxycortisol levels [Time frame: 48 hours]
  • Dynamic 21-Deoxycortisol levels [Time frame: 48 hours]
  • Dynamic 18-Hydroxycortisol levels [Time frame: 48 hours]
  • Dynamic 18-Oxocortisol levels [Time frame: 48 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

China · 1 center
  • Xuanwu Hospital, Beijing — Beijing

Identifiers

NCT: NCT06524479 · 2024-208-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗