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

NCT ID: NCT07305311

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-11-08

Brief Summary

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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

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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.

Conditions

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Refractory Epilepsy Neuromodulation

Keywords

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SEEG Piriform cortex Electrical stimulation Electrophysiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SEEG recordings and SPES effects

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.

Group Type EXPERIMENTAL

SEEG recordings and SPES

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Liankun_Ren

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liankun Ren

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Liankun Ren, MD

Role: CONTACT

Phone: 13681576621

Email: [email protected]

Facility Contacts

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Liankun Ren, MD

Role: primary

Other Identifiers

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2025-292-202

Identifier Type: -

Identifier Source: org_study_id