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High-density Flexible ECoG for Epilepsy Surgery - A Single-Arm ECT

ConditionFocal Epilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-60
SponsorBeijing Tiantan Hospital

About this trial

What's the clinical value of high-density flexible electrocorticography (ECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 3 to 60 years.

Diagnosed with drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed, and adequately tried antiseizure medications.

Diagnosed with focal epilepsy after a standard presurgical epilepsy evaluation and considered suitable for resective epilepsy surgery.

Preoperative Mini-Mental State Examination (MMSE) score ≥ 24.

Disqualifiers

Suspected mesial temporal lobe epilepsy after multidisciplinary presurgical evaluation.

History of any previous neurosurgical craniotomy before epilepsy surgery.

Severe psychiatric, cognitive, or psychological disorder that prevents participation in the study or completion of follow-up.

Contraindication to surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • High-density Flexible Electrocorticography

    Device

    During resective epilepsy surgery, a sterile high-density flexible electrocorticography will be placed on the exposed cortical surface over the suspected epileptogenic zone and adjacent cortex. The array will be used for high-spatial-resolution intraoperative ECoG recording and real-time analysis of epileptiform activity, including interictal spikes, high-frequency oscillations, spatial discharge gradients, and propagation patterns. The intraoperative ECoG findings will be provided to the surgical team to assist in defining the epileptogenic zone and tailoring the extent of resection. The high-density ECoG is used for intraoperative recording only and will be removed before wound closure.

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Intraoperative application of high-density flexible ECoG-Guided ResectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seizure Freedom Rate at 6 Months After Surgery

The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.

Time frame
From surgery to 6 months postoperatively

Secondary outcomes

1

Seizure Freedom Rate at 1 Year After Surgery

The proportion of participants who remain free from any type of epileptic seizure during the 1-year postoperative follow-up period.

Time frame
From surgery to 1 year postoperatively
2

Postoperative Seizure Outcome According to ILAE Classification

Postoperative seizure outcome will be evaluated using the International League Against Epilepsy classification at 6 months and 1 year after surgery. ILAE class 1 indicates complete seizure freedom without aura, and higher classes indicate worse seizure outcomes.

Time frame
6 months and 1 year postoperatively
3

Monthly Seizure Frequency

Monthly seizure frequency will be assessed before surgery and at 6 months and 1 year after surgery. The measure is defined as the average number of epileptic seizures per month.

Time frame
Baseline, 6 months postoperatively, and 1 year postoperatively
4

Seizure Severity Assessed by NHS3

Seizure severity will be assessed using the National Hospital Seizure Severity Scale before surgery and at 6 months and 1 year after surgery.

Time frame
Baseline, 6 months postoperatively, and 1 year postoperatively

Other outcomes

Sponsors and contacts

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

Beijing Tiantan Hospital

Lead sponsor

Beijing Neurosurgical Institute

Sponsor institution

Beijing Fengtai Hospital

Collaborator

Peking University First Hospital

Collaborator

The Chinese University of Hong Kong, Shenzhen

Collaborator

Beijing Xinzhida Neural Technology Co., Ltd

Collaborator

Beijing Neurosurgical Institute

Collaborator

Source ClinicalTrials.gov

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