An interventional study of SEEG recordings and SPES in Refractory Epilepsy and Neuromodulation, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Basic science
The prospective study aims to characterize the network-specific modulatory effects of piriform cortex stimulation in patients undergoing stereotactic EEG for drug-resistant epilepsy. Using multimodal data, it seeks to link stimulation-evoked electrophysiological responses across brain networks with clinical outcomes, to inform targeted neuromodulation therapies.
This study employs stereotactic electroencephalography (SEEG) to investigate the network-specific mechanisms of brain modulation induced by electrical stimulation of the piriform cortex. By analyzing high-density intracranial recordings, combined with structural and functional neuroimaging, the research systematically characterizes how focal stimulation differentially engages and reorganizes activity across large-scale neural circuits. The primary focus is to decode the electrophysiological signatures of network engagement-including changes in spectral power, phase synchronization, and information flow-to reveal fundamental principles of targeted neuromodulation in the human brain.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's planned enrollment of 10 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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Exclusion Criteria:
This arm encompasses patients with drug-resistant focal epilepsy who underwent intracranial monitoring via stereotactically implanted depth electrodes (SEEG) as part of their standard presurgical evaluation. During the monitoring period, these patients additionally underwent systematic Single-Pulse Electrical Stimulation (SPES) mapping. SPES was administered according to a standardized clinical protocol, involving the delivery of single, low-intensity electrical pulses to selected electrode contacts-including those located within or adjacent to the piriform cortex-while recording the evoked electrophysiological responses across the implanted SEEG network. The data collected in this arm include continuous intracranial EEG recordings, precise stimulation parameters (location, intensity), and the corresponding electrophysiological responses used to characterize cortico-cortical evoked potentials and network connectivity.
Device: SEEG recordings and SPES
The intervention involves single-pulse electrical stimulation (SPES) applied during stereotactic electroencephalography (SEEG) monitoring. Low-intensity, standardized electrical pulses are delivered to targeted contacts within or near the piriform cortex via implanted depth electrodes, while simultaneous full-bandwidth SEEG recordings capture network-wide electrophysiological responses, allowing characterization of stimulation-evoked brain network activation and modulation patterns.
Seizure Discharge Suppression Rate
Quantified as the percentage reduction in the frequency of spikes and interictal epileptiform discharges (IEDs) during active stimulation compared to the baseline period.
Time frame: 72 hours
Single-Pulse Stimulation Amplitude:
The minimum current intensity (mA) required to elicit a reproducible response.
Time frame: 72 hours
N1 Component Amplitude and Latency:
Amplitude (μV) and latency (ms) of the primary cortical evoked response (N1 wave).
Time frame: 72 hours
Spatial Distribution of Activation
The extent of cortical activation, assessed by the number of electrode contacts showing significant evoked responses.
Time frame: 72 hours
Effective Connectivity Change：
Alterations in effective connectivity strength (e.g., measured by Granger causality within a 500 ms time window).
Time frame: 72 hours
Phase-Amplitude Coupling Index
Changes in coupling between the phase of low-frequency oscillations and the amplitude of the gamma band (30-80 Hz).
Time frame: 72 hours
Functional Network Reconfiguration
Changes in node centrality metrics (e.g., betweenness centrality, degree centrality) based on graph-theoretical analysis of functional networks.
Time frame: 72 hours
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events: Incidence and severity of adverse events specifically associated with piriform cortex stimulation.
Time frame: 72 hours
Plan to share: No
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Xuanwu Hospital, Beijing