High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-60
SponsorBeijing Tiantan Hospital
About this trial
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 3 to 60 years.
Diagnosis of drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed and adequately tried antiseizure medications.
Diagnosis of focal epilepsy after standard presurgical evaluation and considered suitable for resective epilepsy surgery.
Preoperative cognitive or developmental status sufficient to participate in study assessments, as judged by the investigator and assessed using age-appropriate validated instruments. For participants aged 3 to 6 years, developmental status must be within the normal range according to the Griffiths Mental Development Scales. For participants aged 6 to 16 years, cognitive function must be within the normal range according to the Wechsler Intelligence Scale for Children. For participants older than 16 years, a Mini-Mental State Examination score of 24 or higher will be required.
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
Using High-density Flexible microElectrocorticography for intraoperative monitoring
DeviceDuring resective epilepsy surgery, a sterile high-density flexible microelectrocorticography 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 μECoG 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 μECoG is used for intraoperative recording only and will be removed before wound closure.
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Intraoperative application of high-density flexible μECoG-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 postoperativelySecondary 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 postoperatively2
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 postoperatively3
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 postoperatively4
Seizure Severity Assessed by the National Hospital Seizure Severity Scale
Seizure severity will be assessed using the National Hospital Seizure Severity Scale (NHS3) before surgery and at 6 months and 1 year after surgery. The NHS3 is a seizure severity scale with scores ranging from 1 to 27, with higher scores indicating more severe seizures and therefore a worse outcome.
Time frame
Baseline, 6 months postoperatively, and 1 year postoperativelySponsors 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