UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029989 |
|---|---|
| Receipt number | 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 | 2023/05/30 14:45:11 |
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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 underwent long-term video electroencephalography for epilepsy treatment (prospective)
Patients who is going to undergo long-term video electroencephalography for epilepsy treatment between 2001 and 2017 (retrospective)
Patients who underwent polysomnography for sleep disorder treatment
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
1991
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Miyajima |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Psychosomatic and Palliative Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5673
miholppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Miyajima |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Psychosomatic and Palliative Medicine
Zip code
113-8519
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
Tokyo Medical and Dental University Faculty of Medicine Ethics Review Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
infobec@tmd.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
京都大学、名古屋大学、熊本大学、奈良医療センター、北海道大学、大阪大学、山口県立総合医療センター、国立精神・神経医療研究センター、聖隷浜松病院、順天堂大学、東北大学、土浦協同病院、札幌医科大学、滋賀医科大学、睡眠総合ケアクリニック代々木、クアドリティクス株式会社
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
| 2013 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
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
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034237
| 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 |
