UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047427 |
|---|---|
| Receipt number | R000053668 |
| Scientific Title | A Study on the Evaluation of Epilepsy Treatment with EEG |
| Date of disclosure of the study information | 2022/04/08 |
| Last modified on | 2022/04/07 09:17:32 |
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Basic information
Public title
A Study on the Evaluation of Epilepsy Treatment with EEG
Acronym
A Study on the Evaluation of Epilepsy Treatment with EEG
Scientific Title
A Study on the Evaluation of Epilepsy Treatment with EEG
Scientific Title:Acronym
A Study on the Evaluation of Epilepsy Treatment with EEG
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to generate neuroscientific evidence for the treatment of epilepsy in developmental and adult patients, and to optimize treatment using artificial intelligence based on this evidence.
Basic objectives2
Others
Basic objectives -Others
We will observe imaging tests such as electroencephalogram (EEG) and magnetoencephalogram (MEG), and neuroscientific tests such as cognitive function tests and developmental psychological tests, which are measured before and after pharmacological and surgical treatments for epilepsy, and clarify their relationship with treatment prognosis. Based on the data, we will try to optimize the treatment by artificial intelligence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
seizure frequency (3 months and 12 months after the start of treatment)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In the case of pediatric epilepsy, epilepsy patients 15 years of age or younger who are admitted to the Osaka University Epilepsy Center or Osaka Women and Children Hospital and who can be followed for one year after the start of treatment.
Adult epilepsy patients must be at least 16 years old and attending the Osaka University Hospital or Suita City Hospital, and must be able to be followed for one year after the start of treatment. In both cases, any seizure type is acceptable, and only those who have given written consent will be eligible.
Key exclusion criteria
Those deemed ineligible by the investigator and those whose seizure frequency and type are unknown.
Target sample size
600
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 City, Osaka Prefecture
TEL
06-6879-5111
hkishima@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka University Institute for Advanced Co-creation Studies
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka Prefecture
TEL
06-6879-5111
Homepage URL
tyanagisawa@nsrug.med.osaka-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita City, Osaka Prefecture
Tel
06-6210-8296
handai-nintei@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
| 2022 | Year | 04 | Month | 08 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | 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
Predict seizure prognosis at 1 year based on EEG before and after the start of medication in epilepsy patients. In addition, a cohort will be formed based on medication information, seizure frequency, and neuropsychological testing.
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053668
| 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 |
