Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liankun Ren, MD
- Phone Number: 13681576621
- Email: renlk2022@outlook.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100000
- Recruiting
- Xuanwu Hospital, Beijing
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Contact:
- Liankun Ren, MD
- Phone Number: +86 13681576621
- Email: renlk2022@outlook.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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SEEG recordings with SPES during daytime and sleeptime
Time Frame: 48 hours
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Single-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.
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic melatonin levels
Time Frame: 48 hours
|
Collection 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.
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48 hours
|
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Dynamic cortisone levels
Time Frame: 48 hours
|
Collection 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.
|
48 hours
|
|
Dynamic 11-Deoxycortisol levels
Time Frame: 48 hours
|
Collection 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.
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48 hours
|
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Dynamic 21-Deoxycortisol levels
Time Frame: 48 hours
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Collection 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.
|
48 hours
|
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Dynamic 18-Hydroxycortisol levels
Time Frame: 48 hours
|
Collection 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.
|
48 hours
|
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Dynamic 18-Oxocortisol levels
Time Frame: 48 hours
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Collection 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.
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48 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-208-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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