UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060121 |
|---|---|
| Receipt number | R000068714 |
| Scientific Title | A novel strategy for epilepsy focus surgery: identification of epileptogenic zones using seizures induced during awake surgery |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 13:29:16 |
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Basic information
Public title
A study on identifying epileptogenic zones using seizure information obtained during awake surgery
Acronym
Awake Surgery Seizure Study
Scientific Title
A novel strategy for epilepsy focus surgery: identification of epileptogenic zones using seizures induced during awake surgery
Scientific Title:Acronym
ASSIST-EZ Study
Region
| Japan |
Condition
Condition
Drug-resistant focal epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between symptomatogenic zones identified by seizure symptoms and electroencephalographic findings induced by cortical electrical stimulation during awake surgery, and the final epileptogenic zone.
Key secondary outcomes
Postoperative seizure outcome at 1 year
Occurrence of serious adverse events related to intraoperative electrical stimulation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Hirose |
Organization
Fujita Health University
Division name
Department of Neurosurgery, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-9253
yhirose@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Kumon |
Organization
Fujita Health University
Division name
Department of Neurosurgery, School of Medicine
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562939253
Homepage URL
d.m.kumon@gmail.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Fujita Health University
Address
Fujita Health University 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
Tel
0562-93-9000
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068714
