Focal EpilepsyEpi-PRECISENCT07656857
High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT
A study testing Using High-density Flexible microElectrocorticography for intraoperative monitoring in people with Focal Epilepsy and Intraoperative Monitoring, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery? Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Focal Epilepsy, Intraoperative Monitoring
- What is being tested?
- Using High-density Flexible microElectrocorticography for intraoperative monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2028
- 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- Written informed consent provided by the participant or, when applicable, by a legal guardian.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Du Cai Dr, 86 01059975051, ferryc22@163.com
About this study
Official title: Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
Read the detailed description
- Compare the effect of intraoperative high-density flexible μECoG guidance versus no intraoperative μECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
- Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
- Conditions
- Focal Epilepsy, Intraoperative Monitoring
- Being tested
- Using High-density Flexible microElectrocorticography for intraoperative monitoring
- Keywords
- Epilepsy surgery, microelectrocorticography (μECoG)
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using High-density Flexible microElectrocorticography for intraoperative monitoringDevice
During 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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative application of high-density flexible μECoG-Guided Resection | Experimental | Not described Receives: Device: Using High-density Flexible microElectrocorticography for intraoperative monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery to 6 months postoperatively
Secondary outcomes (11)
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.
Measured: From surgery to 1 year postoperatively
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.
Measured: 6 months and 1 year postoperatively
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.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
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.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
Developmental Function Assessed by the Griffiths Mental Development Scales
For participants aged 3 to 6 years, developmental function will be evaluated using the Griffiths Mental Development Scales before surgery and at 6 months and 1 year after surgery. The primary reported score will be the General Developmental Quotient or General Quotient. The quotient score ranges from 50 to 150, with higher scores indicating better developmental function and therefore a better outcome.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Wechsler Intelligence Scale for Children
For participants aged 6 to 16 years, cognitive function will be evaluated using the Wechsler Intelligence Scale for Children before surgery and at 6 months and 1 year after surgery. The primary reported score will be the Full Scale Intelligence Quotient. The Full Scale Intelligence Quotient standard score ranges from 40 to 160, with higher scores indicating better cognitive function and therefore a better outcome.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Mini-Mental State Examination
For participants older than 16 years, cognitive function will be evaluated using the Mini-Mental State Examination (MMSE) before surgery and at 6 months and 1 year after surgery. The MMSE total score ranges from 0 to 30, with higher scores indicating better cognitive function and therefore a better outcome.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0
Quality of life will be evaluated before surgery and at 6 months and 1 year after surgery. Adult participants will be assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and pediatric participants will be assessed using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0). Both scales are transformed to scores ranging from 0 to 100, with higher scores indicating better quality of life and therefore a better outcome.
Measured: Baseline, 6 months postoperatively, and 1 year postoperatively
Postoperative Complications
The incidence of postoperative complications, including infection, fever, neurological deficits, and other surgery-related complications, will be recorded during the perioperative period and postoperative follow-up.
Measured: Perioperative period, 6 months postoperatively, and 1 year postoperatively
Surgery-Related Adverse Events
The incidence of surgery-related adverse events will be recorded during the perioperative period. Adverse events include events directly related to the surgical procedure.
Measured: Perioperative period
Serious Adverse Events
The incidence of serious adverse events, including postoperative death or severe deterioration of health status during the perioperative period, will be recorded.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Focal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Fengtai Hospital, Peking University First Hospital, The Chinese University of Hong Kong, Shenzhen, Beijing Xinzhida Neural Technology Co., Ltd, Beijing Neurosurgical Institute
- Responsible party
- Principal investigator, Kai Zhang, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656857
- Sponsor's protocol ID
- KY2026-169-02
- Acronym
- Epi-PRECISE
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xingjian Liu, Chao Zhang, Baotian Zhao, et al., Preliminary application study of flexible high-density cortical electrodes in assisting localization of epileptogenic zones during epileptogenic zonectomy, Chinese Journal of Neurosurgery, 2025, 41(12):1237-1244. DOI:10.3760/cma.j.cn112050-20250919-00362
Guo J, Wang Z, van 't Klooster MA, Van Der Salm SM, Leijten FS, Braun KP, Zijlmans M. Seizure Outcome After Intraoperative Electrocorticography-Tailored Epilepsy Surgery: A Systematic Review and Meta-Analysis. Neurology. 2024 Jun 11;102(11):e209430. doi: 10.1212/WNL.0000000000209430. Epub 2024 May 20.
PubMed 38768406
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
- ClinicalTrials.gov ID
- NCT07656857
- Acronym / sponsor ID
- Epi-PRECISE / KY2026-169-02
- Conditions
- Focal Epilepsy, Intraoperative Monitoring
- Keywords
- Epilepsy surgery, microelectrocorticography (μECoG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Fengtai Hospital, Peking University First Hospital, The Chinese University of Hong Kong, Shenzhen, Beijing Xinzhida Neural Technology Co., Ltd, Beijing Neurosurgical Institute
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
Detailed description
- Compare the effect of intraoperative high-density flexible μECoG guidance versus no intraoperative μECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
- Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative application of high-density flexible μECoG-Guided Resection | Experimental | Device: Using High-density Flexible microElectrocorticography for intraoperative monitoring |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- Written informed consent provided by the participant or, when applicable, by a legal guardian.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Using High-density Flexible microElectrocorticography for intraoperative monitoringDuring 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. | Device | Intraoperative application of high-density flexible μECoG-Guided Resection |
Primary outcome
Seizure Freedom Rate at 6 Months After Surgery
Time frame: From surgery to 6 months postoperatively
The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
11 secondary outcomes
Seizure Freedom Rate at 1 Year After Surgery
Time frame: From surgery to 1 year postoperatively
Postoperative Seizure Outcome According to ILAE Classification
Time frame: 6 months and 1 year postoperatively
Monthly Seizure Frequency
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Seizure Severity Assessed by the National Hospital Seizure Severity Scale
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Developmental Function Assessed by the Griffiths Mental Development Scales
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Wechsler Intelligence Scale for Children
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by the Mini-Mental State Examination
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0
Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Postoperative Complications
Time frame: Perioperative period, 6 months postoperatively, and 1 year postoperatively
Surgery-Related Adverse Events
Time frame: Perioperative period
Serious Adverse Events
Time frame: Perioperative period
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 13 Aug 2026.
- BackgroundXingjian Liu, Chao Zhang, Baotian Zhao, et al., Preliminary application study of flexible high-density cortical electrodes in assisting localization of epileptogenic zones during epileptogenic zonectomy, Chinese Journal of Neurosurgery, 2025, 41(12):1237-1244. DOI:10.3760/cma.j.cn112050-20250919-00362
- Background: PubMed 38768406Guo J, Wang Z, van 't Klooster MA, Van Der Salm SM, Leijten FS, Braun KP, Zijlmans M. Seizure Outcome After Intraoperative Electrocorticography-Tailored Epilepsy Surgery: A Systematic Review and Meta-Analysis. Neurology. 2024 Jun 11;102(11):e209430. doi: 10.1212/WNL.0000000000209430. Epub 2024 May 20.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using High-density Flexible microElectrocorticography for intraoperative monitoring in people with Focal Epilepsy and Intraoperative Monitoring, run by Beijing Tiantan Hospital 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Kai Zhang Dr (86 01059975051, zhangkai62035@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Freedom Rate at 6 Months After Surgery (time frame: From surgery to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07656857, which also lists 2 linked publications.
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 13 Aug 2026.