UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029990 |
|---|---|
| Receipt number | R000034248 |
| Scientific Title | Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients |
| Date of disclosure of the study information | 2017/11/16 |
| Last modified on | 2018/05/17 11:34:55 |
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Basic information
Public title
Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Acronym
Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Scientific Title
Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Scientific Title:Acronym
Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing a seizure prediction system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological prediction performance index of seizure prediction system: sensitivity 95% and false positive frequency 0.1 times/h
Evaluation time: from the eighth week on both index
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Implementation test of the seizure prediction device: 0 to 8th week
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
Patients who are hospitalized for epilepsy treatment and who performs long-term video EEG examination
Patients who are hospitalized for epilepsy treatment but who do not performs long-term video EEG examination
Outpatient patients for epilepsy diagnosis
Key exclusion criteria
Patients who are judged inappropriate by a doctor
ex) patients who can not wear a device due to serious complications, uncooperative patients etc.)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Miyajima |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Psychosomatic and Palliative Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5673
miholppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Miyajima |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Psychosomatic and Palliative Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5673
Homepage URL
miholppm@tmd.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
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
| 2017 | Year | 11 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 31 | 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
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034248
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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