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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046442
Receipt No. R000052926
Scientific Title Usability confirmation test of mobile electroencephalograph in clinical environment
Date of disclosure of the study information 2022/01/10
Last modified on 2021/12/22

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Basic information
Public title Performance test of mobile electroencephalograph in hospital environment
Acronym Performance test of mobile electroencephalograph in hospital environment
Scientific Title Usability confirmation test of mobile electroencephalograph in clinical environment
Scientific Title:Acronym Usability confirmation test of mobile electroencephalograph in clinical environment
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirmation of the usability of the dry sensor type simple electroencephalograph in a clinical environment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the test device and the electroencephalograph obtained with the target device.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Adults without physical or mental illness.
Key exclusion criteria Those who have undergone head surgery, who are participating in other clinical studies or clinical trials, who are pregnant.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Tomita
Organization Tohoku University, Graduate school of Medicine
Division name Department of Psychiatry
Zip code 9808574
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL 0227177000
Email htomita@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Sakuma
Organization Tohoku University Hospital
Division name Department of Psychiatry
Zip code 9808574
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL 0227177000
Homepage URL
Email atsushi.sakuma.a1@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
Tel 0227284105
Email 0227284105

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
2022 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 11 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2021 Year 12 Month 22 Day
Last modified on
2021 Year 12 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052926

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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