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NCT Number: NCT07305311

Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG

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.

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases Neuromodulation

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEEG recordings and SPES

Device

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 outcomes

  1. Seizure Discharge Suppression Rate

    Time frame: 72 hours

    Quantified as the percentage reduction in the frequency of spikes and interictal epileptiform discharges (IEDs) during active stimulation compared to the baseline period.

Secondary outcomes

  1. Single-Pulse Stimulation Amplitude:

    Time frame: 72 hours

    The minimum current intensity (mA) required to elicit a reproducible response.

  2. N1 Component Amplitude and Latency:

    Time frame: 72 hours

    Amplitude (μV) and latency (ms) of the primary cortical evoked response (N1 wave).

  3. Spatial Distribution of Activation

    Time frame: 72 hours

    The extent of cortical activation, assessed by the number of electrode contacts showing significant evoked responses.

  4. Effective Connectivity Change：

    Time frame: 72 hours

    Alterations in effective connectivity strength (e.g., measured by Granger causality within a 500 ms time window).

  5. Phase-Amplitude Coupling Index

    Time frame: 72 hours

    Changes in coupling between the phase of low-frequency oscillations and the amplitude of the gamma band (30-80 Hz).

  6. Functional Network Reconfiguration

    Time frame: 72 hours

    Changes in node centrality metrics (e.g., betweenness centrality, degree centrality) based on graph-theoretical analysis of functional networks.

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 72 hours

    Adverse Events: Incidence and severity of adverse events specifically associated with piriform cortex stimulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Liankun Ren, MD

CONTACT

[email protected]

13681576621

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG With Multimodal Data Integration

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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