UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019487 |
|---|---|
| Receipt number | R000022534 |
| Scientific Title | Innovation of novel diagnostic system for epileptogenic focus and propagation pathway in epilepsy by EEG-fMRI simultaneous recording |
| Date of disclosure of the study information | 2015/10/25 |
| Last modified on | 2015/11/29 07:20:36 |
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Basic information
Public title
Innovation of novel diagnostic system for epileptogenic focus and propagation pathway in epilepsy by EEG-fMRI simultaneous recording
Acronym
focus detection by EEG-fMRI for epilepsy
Scientific Title
Innovation of novel diagnostic system for epileptogenic focus and propagation pathway in epilepsy by EEG-fMRI simultaneous recording
Scientific Title:Acronym
focus detection by EEG-fMRI for epilepsy
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish diagnostic system for focus detection in epilepsy patients using EEG-fMRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
senstivity and specificity analyzed by cluster recorded by EEG-fMRI copared to epileptic focus detected by other modalities
Key secondary outcomes
usefulness for EEG-fMRI for epilepsy surgery by analyzing the locations of the cluster and resection area
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
perform EEG-fMRI
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
| 6 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
epilepsy patients
obtained informed consent
Key exclusion criteria
not obrtained IC
severe psychiastric disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Maesawa |
Organization
Nagoya University School of Medicine
Division name
Brain and Mind Research Center, Neurosurgery
Zip code
Address
Tsurumai65, Showa, Nagoya
TEL
052-744-2353
smaesawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Maesawa |
Organization
Nagoya University School of Medicine
Division name
Brain and Mind Research Center, Neurosurgery
Zip code
Address
Tsurumai65, Showa, Nagoya
TEL
052-744-2353
Homepage URL
smaesawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Brain and Mind Research Center
Institute
Department
Personal name
Funding Source
Organization
Brain and Mind Research Center
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
Address
Tel
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
| 2015 | Year | 10 | Month | 25 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 25 | Day |
Last modified on
| 2015 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022534
