UMIN-CTR Clinical Trial

Basic information
Public title	Factors of seizure outcome after epilepsy surgery
Acronym	Factors of seizure outcome after epilepsy surgery
Scientific Title	Factors of seizure outcome after epilepsy surgery
Scientific Title:Acronym	Factors of seizure outcome after epilepsy surgery
Region	Japan

Condition
Condition	intractable epilepsy
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the effects of various factors involved in epilepsy surgery on seizure outcome
Basic objectives2	Others
Basic objectives -Others	n/a
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between seizure outcome and various medical information
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	2 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. patients wihtintractable epilepsy 2. patients implanted electrodes 3. patients with undergone EEG monitoring 4. patients with undergone brain functional mapping
Key exclusion criteria	1. If complications occur during the postoperative course 2. Patients judged by the principal investigator to be inappropriate as research subjects
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuich Middle name Last name Kubota
Organization	Tokyo Women's Medical University,Adachi Medical Center
Division name	Neurosurgery
Zip code	1238558
Address	Kohoku 4-33-1, Adachi, Tokyo
TEL	03-3857-0111
Email	yuchan2913@yahoo.co.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Kubota
Organization	Tokyo Women's Medical University,Adachi Medical Center
Division name	Neurosurgery
Zip code	1168567
Address	Kohoku 4-33-1, Adachi, Tokyo
TEL	03-3857-0111
Homepage URL
Email	yuchan2913@yahoo.co.jp

Sponsor
Institute	Tokyo Women's Medical University,Adachi Medical Center
Institute
Department

Funding Source
Organization	n/a
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Women's Medical University,Adachi Medical Center
Address	Kohoku 4-33-1, Adachi, Tokyo
Tel	03-3857-0111
Email	yuchan2913@yahoo.co.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	2021 Year 01 Month 30 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 10 Day
Date of IRB	2020 Year 10 Month 10 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	n/a

Management information
Registered date	2021 Year 01 Month 20 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049008