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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034292
Receipt No. R000039095
Scientific Title Study on change of connectivity and the brain structure in the lacunar infarction patients
Date of disclosure of the study information 2018/09/27
Last modified on 2018/09/27

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Basic information
Public title Study on change of connectivity and the brain structure in the lacunar infarction patients
Acronym Study on change of connectivity and the brain structure in the lacunar infarction patients
Scientific Title Study on change of connectivity and the brain structure in the lacunar infarction patients
Scientific Title:Acronym Study on change of connectivity and the brain structure in the lacunar infarction patients
Region
Japan

Condition
Condition Ischemic stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In lacunar infarction patients, We compare the changes in body function, cognitive function, brain structure using MRI.
Basic objectives2 Others
Basic objectives -Others We investigate the association of each data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of the brain structure of various MRI
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria (1)Initial attack of stroke
(2)Infarction in the territory of the perforating arteries of the MCA, which should be defined by MR DW image.
(3)Informed consent
Key exclusion criteria (1) Severe past history of brain, psychologycal disease
(2) Metalic implant (pace maker, coronaly stent, artificial joint, etc.)
(3) Claustrophobia
(4) Do not (cannot) concent to this study
(5) Who assessed as not suitable for this study by conducting doctors
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taki Yasuyuki
Organization IDAC, Tohoku University
Division name Depertment of nuclear medicine and Radiology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL 022-717-8559
Email yasuyuki.taki.c7@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mutoh Tatsushi
Organization IDAC, Tohoku University
Division name Depertment of nuclear medicine and Radiology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL 022-717-8559
Homepage URL
Email tmutoh@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
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
2018 Year 09 Month 27 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039095

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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