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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029989
Receipt No. R000034237
Scientific Title Development of a algorithm for epileptic seizure prediction based on heart rate variability monitoring
Date of disclosure of the study information 2017/11/16
Last modified on 2018/11/22

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Basic information
Public title Development of a algorithm for epileptic seizure prediction based on heart rate variability monitoring
Acronym Development of a algorithm for epileptic seizure prediction based on heart rate variability monitoring
Scientific Title Development of a algorithm for epileptic seizure prediction based on heart rate variability monitoring
Scientific Title:Acronym Development of a algorithm for epileptic seizure prediction based on heart rate variability monitoring
Region
Japan

Condition
Condition epilepsy
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Developing a seizure prediction algorithm for epileptic seizure prediction
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 third week on both index
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 Patient who performs long-term video electroencephalography for epilepsy treatment (prospective)
Patients who had long-term video electroencephalography for epilepsy treatment between 2001 and 2017 (retrospective)
Key exclusion criteria No exclusion criteria. However, if it is judged to be exceptional at the time of data analysis, data will be excluded at that point.
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 Partially published

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
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 epileptic seizures were predictable at least one minite prior to the clinical onset

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034237

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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