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

NCT07305311 | Not Yet Recruiting

• 1 other identifier: 2025-292-202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Epilepsy; Neuromodulation

Keywords

SEEG; Piriform cortex; Electrical stimulation; Electrophysiology

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Secondary Outcomes (7)

• Single-Pulse Stimulation Amplitude:

  72 hours

• N1 Component Amplitude and Latency:

  72 hours

• Spatial Distribution of Activation

  72 hours

• Effective Connectivity Change：

  72 hours

• Phase-Amplitude Coupling Index

  72 hours

Study Arms (1)

SEEG recordings and SPES effects

EXPERIMENTAL

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

Interventions

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.

SEEG recordings and SPES effects

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects that experience surgical complications during the implant procedure will be excluded from the study

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liankun Ren

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 26, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): November 8, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)