Refractory EpilepsyNCT07305311
Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG
A study testing SEEG recordings and SPES in people with Refractory Epilepsy and Neuromodulation, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Refractory Epilepsy, Neuromodulation
- What is being tested?
- SEEG recordings and SPES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 8 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects that experience surgical complications during the implant procedure will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
About this study
Official title: Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG With Multimodal Data Integration
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.
Read the 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.
- Conditions
- Refractory Epilepsy, Neuromodulation
- Being tested
- SEEG recordings and SPES
- Keywords
- SEEG, Piriform cortex, Electrical stimulation, Electrophysiology
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEG recordings and SPESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SEEG recordings and SPES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (7)
Single-Pulse Stimulation Amplitude:
The minimum current intensity (mA) required to elicit a reproducible response.
Measured: 72 hours
N1 Component Amplitude and Latency:
Amplitude (μV) and latency (ms) of the primary cortical evoked response (N1 wave).
Measured: 72 hours
Spatial Distribution of Activation
The extent of cortical activation, assessed by the number of electrode contacts showing significant evoked responses.
Measured: 72 hours
Effective Connectivity Change：
Alterations in effective connectivity strength (e.g., measured by Granger causality within a 500 ms time window).
Measured: 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).
Measured: 72 hours
Functional Network Reconfiguration
Changes in node centrality metrics (e.g., betweenness centrality, degree centrality) based on graph-theoretical analysis of functional networks.
Measured: 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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Dec 2025 (estimated)
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305311
- Sponsor's protocol ID
- 2025-292-202
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising the Network-Specific Effects of Piriform Cortex Stimulation Via SEEG With Multimodal Data Integration
- ClinicalTrials.gov ID
- NCT07305311
- Acronym / sponsor ID
- 2025-292-202
- Conditions
- Refractory Epilepsy, Neuromodulation
- Keywords
- SEEG, Piriform cortex, Electrical stimulation, Electrophysiology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 8 Dec 2025 (estimated)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Nov 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEEG recordings and SPES effects | Experimental | Device: SEEG recordings and SPESThis 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects that experience surgical complications during the implant procedure will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEEG recordings and SPESThe 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. | Device | SEEG recordings and SPES effects |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liankun Ren principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEG recordings and SPES in people with Refractory Epilepsy and Neuromodulation, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liankun Ren, MD (13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Discharge Suppression Rate (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.