UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038686 |
|---|---|
| Receipt number | R000043079 |
| Scientific Title | Exploratory research for magnetoencephalography findings in juvenile myoclonic epilepsy |
| Date of disclosure of the study information | 2019/11/26 |
| Last modified on | 2024/03/04 14:17:51 |
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Basic information
Public title
Exploratory research for magnetoencephalography findings in juvenile myoclonic epilepsy
Acronym
Exploratory research for MEG findings in JME
Scientific Title
Exploratory research for magnetoencephalography findings in juvenile myoclonic epilepsy
Scientific Title:Acronym
Exploratory research for MEG findings in JME
Region
| Japan |
Condition
Condition
Juvenile myoclonic epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal magnetoencephalography findings in juvenile myoclonic epilepsy in which mechanism of primary bilateral synchrony is assumed.
Basic objectives2
Others
Basic objectives -Others
Laboratory findings
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MEG findings: interhemispheric time difference at the onset of activated zone on gradient magnetic field topography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnetoencephalography
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were clinically diagnosed as juvenile myoclonic epilepsy with generalized spike-and-wave on electroencephalography.
Key exclusion criteria
Asymmetrical generalized spike-and-wave on electroencephalography
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Iida |
Organization
Hiroshima University Hospital
Division name
Department of Neurosurgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
0822575227
iidak@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Kagawa |
Organization
Hiroshima University Hospital
Division name
Department of Neurosurgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
0822575227
Homepage URL
kotakgw@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Early-Career Scientists, Grant-in-Aid for Scientific Research
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
Center for Integrated Medical Research, Hiroshima University Hospital
Address
Minami-ku Kasumi 1-2-3
Tel
082-257-1732
protocol@cimr.hiroshima-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 | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043079
