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A study on identifying epileptogenic zones using seizure information obtained during awake surgery

A novel strategy for epilepsy focus surgery: identification of epileptogenic zones using seizures induced during awake surgery - ASSIST-EZ Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060121
Enrollment
60
Registered
2025-12-18
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-resistant focal epilepsy

Interventions

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

Sponsors

Fujita Health University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Concordance between symptomatogenic zones identified by seizure symptoms and electroencephalographic findings induced by cortical electrical stimulation during awake surgery, and the final epileptogenic zone.

Secondary

MeasureTime frame
Postoperative seizure outcome at 1 year Occurrence of serious adverse events related to intraoperative electrical stimulation

Countries

Japan

Contacts

Public ContactMasanobu Kumon

Fujita Health University Department of Neurosurgery, School of Medicine

d.m.kumon@gmail.com0562939253

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026