Tokyo, Dec. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060121) titled 'A study on identifying epileptogenic zones using seizure information obtained during awake surgery' on Dec. 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - Drug-resistant focal epilepsy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To analyze clinical symptoms and electroencephalographic findings of seizures induced by cortical electrical stimulation during awake surgery, and to clarify their relationship with symptomatogenic and epileptogenic zones. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - During awake craniotomy, electrical cortical or intraparenchymal stimulation is performed to provoke seizures or seizure-like activities. Stimulation is delivered using a cortical mapping stimulator or implanted electrodes at intensities ranging from 2 to 18 mA for several seconds in a stepwise manner. Continuous intraoperative EEG monitoring is conducted to record after-discharges and clinical seizure symptoms. If a seizure is induced, stimulation is immediately discontinued and appropriate safety measures, such as cold saline irrigation, are applied. The intervention is performed only during the surgical procedure.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with drug-resistant focal-onset epilepsy

Patients deemed eligible for awake craniotomy based on preoperative evaluation and EEG conference

Patients undergoing electrical stimulation during awake surgery for epileptogenic zone identification

Or patients who previously underwent awake craniotomy for brain tumor resection in whom seizures were incidentally provoked by cortical stimulation Key exclusion criteria - Patients considered unsuitable for safe awake surgery due to cognitive, psychiatric, or general medical conditions

Patients in whom responses to intraoperative electrical stimulation are expected to be unrecordable or unevaluable

Patients who do not provide informed consent (by the patient or proxy) Target Size - 60

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 04 Month 25 Day Date of IRB - 2026 Year 01 Month 05 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068714

Disclaimer: Curated by HT Syndication.