An interventional study of SEEG recordings and SPES in Refractory Epilepsy and Sleep, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Basic science
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.
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.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 208 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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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.
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 characterization of state-dependent neural network dynamics.
SEEG recordings with SPES during daytime and sleeptime
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.
Time frame: 48 hours
Dynamic melatonin levels
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.
Time frame: 48 hours
Dynamic cortisone levels
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.
Time frame: 48 hours
Dynamic 11-Deoxycortisol levels
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.
Time frame: 48 hours
Dynamic 21-Deoxycortisol levels
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.
Time frame: 48 hours
Dynamic 18-Hydroxycortisol levels
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.
Time frame: 48 hours
Dynamic 18-Oxocortisol levels
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.
Time frame: 48 hours
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Xuanwu Hospital, Beijing