Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG
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, Neuromodulation. 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 →
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Official title
Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG With Multimodal Data Integration
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Seizure Discharge Suppression Rate [Time frame: 72 hours]
Secondary outcome measures (7)
- Single-Pulse Stimulation Amplitude: [Time frame: 72 hours]
- N1 Component Amplitude and Latency: [Time frame: 72 hours]
- Spatial Distribution of Activation [Time frame: 72 hours]
- Effective Connectivity Change： [Time frame: 72 hours]
- Phase-Amplitude Coupling Index [Time frame: 72 hours]
- Functional Network Reconfiguration [Time frame: 72 hours]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 72 hours]
Eligibility criteria
Inclusion criteria
- The patients were diagnosed with drug-resistant epilepsy.
- The patients underwent stereoelectroencephalography (SEEG) implantation for pre-surgical evaluation of epilepsy, with at least one electrode target reaching the piriform cortex
- Participants/parents/legal guardian provide informed consent for inclusion
Exclusion criteria
- 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
Identifiers
NCT: NCT07305311 · 2025-292-202