UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030494 |
|---|---|
| Receipt number | R000034809 |
| Scientific Title | Research on development of wearable epilepsy monitoring device |
| Date of disclosure of the study information | 2017/12/21 |
| Last modified on | 2024/06/25 09:52:51 |
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Basic information
Public title
Research on development of wearable epilepsy monitoring device
Acronym
Research on development of wearable epilepsy monitoring device
Scientific Title
Research on development of wearable epilepsy monitoring device
Scientific Title:Acronym
Research on development of wearable epilepsy monitoring device
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | 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
Heart Rate, Acceleration, Breathing, EMG, Voice, Body Motion
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 diagnosed with epilepsy or suspected epilepsy
Key exclusion criteria
Patients with metal allergy
Target sample size
1000
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、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、新宿神経クリニック、土浦協同病院、クアドリティクス株式会社
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 21 | 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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034809
