UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Evaluation of Epilepsy Treatment with EEG
Acronym	A Study on the Evaluation of Epilepsy Treatment with EEG
Scientific Title	A Study on the Evaluation of Epilepsy Treatment with EEG
Scientific Title:Acronym	A Study on the Evaluation of Epilepsy Treatment with EEG
Region	Japan

Condition
Condition	Epilepsy
Classification by specialty	Neurology Pediatrics Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to generate neuroscientific evidence for the treatment of epilepsy in developmental and adult patients, and to optimize treatment using artificial intelligence based on this evidence.
Basic objectives2	Others
Basic objectives -Others	We will observe imaging tests such as electroencephalogram (EEG) and magnetoencephalogram (MEG), and neuroscientific tests such as cognitive function tests and developmental psychological tests, which are measured before and after pharmacological and surgical treatments for epilepsy, and clarify their relationship with treatment prognosis. Based on the data, we will try to optimize the treatment by artificial intelligence.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	seizure frequency (3 months and 12 months after the start of treatment)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	In the case of pediatric epilepsy, epilepsy patients 15 years of age or younger who are admitted to the Osaka University Epilepsy Center or Osaka Women and Children Hospital and who can be followed for one year after the start of treatment. Adult epilepsy patients must be at least 16 years old and attending the Osaka University Hospital or Suita City Hospital, and must be able to be followed for one year after the start of treatment. In both cases, any seizure type is acceptable, and only those who have given written consent will be eligible.
Key exclusion criteria	Those deemed ineligible by the investigator and those whose seizure frequency and type are unknown.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Haruhiko Middle name Last name Kishima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita City, Osaka Prefecture
TEL	06-6879-5111
Email	hkishima@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takufumi Middle name Last name Yanagisawa
Organization	Osaka University Institute for Advanced Co-creation Studies
Division name	Department of Neurosurgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita City, Osaka Prefecture
TEL	06-6879-5111
Homepage URL
Email	tyanagisawa@nsrug.med.osaka-u.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka, Suita City, Osaka Prefecture
Tel	06-6210-8296
Email	handai-nintei@hp-crc.med.osaka-u.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	2022 Year 04 Month 08 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	2019 Year 09 Month 24 Day
Date of IRB	2020 Year 01 Month 23 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Predict seizure prognosis at 1 year based on EEG before and after the start of medication in epilepsy patients. In addition, a cohort will be formed based on medication information, seizure frequency, and neuropsychological testing.

Management information
Registered date	2022 Year 04 Month 07 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053668