UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on change of connectivity and the brain structure in the lacunar infarction patients
Title of the study (Brief title)	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	Taki Yasuyuki
Organization	IDAC, Tohoku University
Division name	Depertment of nuclear medicine and Radiology
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	Mutoh Tatsushi
Organization	IDAC, Tohoku University
Division name	Depertment of nuclear medicine and Radiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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