Health TrialsbyHealthPanel

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

ConditionsRefractory EpilepsyNeuromodulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: SEEG recordings and SPES effectsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
72 hours

Secondary outcomes

1

Single-Pulse Stimulation Amplitude:

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

Time frame
72 hours
2

N1 Component Amplitude and Latency:

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

Time frame
72 hours
3

Spatial Distribution of Activation

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

Time frame
72 hours
4

Effective Connectivity Change：

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

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: