UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036866 |
|---|---|
| Receipt number | 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 00:53:15 |
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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
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
khoo@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Universtiy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
