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Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06524479
Enrollment
20
Registered
2024-07-29
Start date
2024-07-08
Completion date
2027-10-08
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy, Sleep

Keywords

homeostatic sleep pressure, synaptic plasticity

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.

Interventions

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.

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SEEG recordings with SPES during daytime and sleeptime48 hoursSingle-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.

Secondary

MeasureTime frameDescription
Dynamic cortisone levels48 hoursCollection of salivary cortisone during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Dynamic 11-Deoxycortisol levels48 hoursCollection of salivary 11-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Dynamic melatonin levels48 hoursCollection of melatonin during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement. Salivary melatonin was measured by radioimmunoassay.
Dynamic 18-Hydroxycortisol levels48 hoursCollection of salivary 18-Hydroxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Dynamic 18-Oxocortisol levels48 hoursCollection of salivary 18-Oxocortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.
Dynamic 21-Deoxycortisol levels48 hoursCollection of salivary 21-Deoxycortisol during the day (12 times a day: at 9:00 am, 10:00 am, 11:00 am, 2:00pm, 3:00pm, 4:00pm, 5:00pm, 7:00pm, 8:00pm, 9:00pm, 10:00pm , 11:00pm and 12:00pm) with salivette measurement.

Countries

China

Contacts

Primary ContactLiankun Ren, MD
renlk2022@outlook.com13681576621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026