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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029990
Receipt No. 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

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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
Email 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
Email miholppm@tmd.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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