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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036866
Receipt No. R000041665
Scientific Title Epileptic network analysis using simultaneous EEG-fMRI
Date of disclosure of the study information 2019/05/28
Last modified on 2019/05/28

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Basic information
Public title Simultaneous EEG-fMRI on patients with epilepsy
Acronym Simultaneous EEG-fMRI on patients with epilepsy
Scientific Title Epileptic network analysis using simultaneous EEG-fMRI
Scientific Title:Acronym Epileptic network analysis using simultaneous EEG-fMRI
Region
Japan

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

Objectives
Narrative objectives1 This study aims to delineate the epileptogenic zone and network non-invasively using simultaneous EEG-fMRI.
Basic objectives2 Others
Basic objectives -Others to delineate the epileptogenic zone and network
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical implication of the epileptogenic zone and network delineated using EEG-fMRI
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects included in this study must fulfill the following criteria:
(1) Patients diagnosed with epilepsy, based on the Japanese Guidelines for Epilepsy Management 2018, (2) regardless of their disease duration and gender.
(3) Patients who gave consent to participate. Written consent will be obtained from the patients themselves for those who are 20 years and above, capable of making informed and rational judgement. Written consent will be obtained from the their representative (for example parents or guardian) for those who are below 20 years or lack the capability to make informed and rational judgement.
Key exclusion criteria Subjects who fulfill any of the following criteria will be excluded from this study.
1) Individuals with severe intellectual disability in whom proper communication is not possible and thus unable to stay still during the acquisition of MRI.
2) Individuals who are unable to cooperate and unable to stay still during the acquisition of MRI (for example some patients below 17 years).
3) Individuals who are contraindicated for MRI (those implanted with pacemaker or artificial cardiac valve, and those who are claustrophobic).
4) Individuals considered incompetent to participate in this study, by the attending physician.
Target sample size 50

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, Japan.
TEL 06-6879-3652
Email hkishima@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hui Ming
Middle name
Last name Khoo
Organization Osaka University, Graduate School of Medicine
Division name Department of Neurosurgery
Zip code 565-0871
Address 2-2, Yamadaoka, Suita, Japan.
TEL 06-6879-3652
Homepage URL
Email khoo@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka Universtiy
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (Tokyo)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
Tel 06-6210-8289
Email rinri@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
2019 Year 05 Month 28 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 02 Month 08 Day
Date of IRB
2019 Year 02 Month 08 Day
Anticipated trial start date
2019 Year 04 Month 26 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 Non-randomized non-blinded prospective case series study

Management information
Registered date
2019 Year 05 Month 28 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041665

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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