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

Qualifiers

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

Treatments tested in this trial

  • Using High-density Flexible microElectrocorticography for intraoperative monitoring

Treatment groups

85 Participants
are divided into 1 treatment group

Sponsors and collaborators

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