UMIN-CTR Clinical Trial

Basic information
Public title	The association of stroke in cerebellar with cognitive function
Acronym	The association of stroke in cerebellar with cognitive function
Scientific Title	The association of stroke in cerebellar with cognitive function
Scientific Title:Acronym	The association of stroke in cerebellar with cognitive function
Region	Japan

Condition
Condition	stroke
Classification by specialty	Neurology Geriatrics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the association of stroke in cerebellar with cognitive impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is to elucidate whether cognitive impairment might occur 6 months after stroke in cerebellar.
Key secondary outcomes	The secondary outcome is to elucidate whether psychological disorder might occur in stroke in cerebellar. Also we are going to evaluate the role of imaging findings for the prediction of cognitive impairment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	functional near-infrared spectroscopy (fNIRS) high-resolution volumetric T1 weighted image It is going to be performed twice, 2 weeks and 6 months after stroke.
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	The patients with ischemic or hemorrhagic stroke in cerebellar who were admitted in our hospital within 7 days of onset were enrolled in this study. Whether each patient has cerebellar stroke was defined by his or her medical history, neurological and imaging findings.
Key exclusion criteria	The patients who have stroke in cerebral hemisphere, who were previously diagnosed to have cognitive impairment, consciousness disturbance or hemiplegia are excluded from this study. Also, those who do not approved to attend this study are excluded.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Toshiyasu Middle name Last name Ogata
Organization	Fukuoka University
Division name	Department of Neurology
Zip code	814-0180
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	toshiogata@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Ogata
Organization	Fukuoka University
Division name	Department of Neurology
Zip code	814-0180
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	toshiogata@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical research assist center
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka
Tel	092-801-1011
Email	rinshou@adm.fukuoka-u.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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 16 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	Completed
Date of protocol fixation	2016 Year 03 Month 10 Day
Date of IRB	2016 Year 03 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date	2019 Year 05 Month 30 Day
Date of closure to data entry	2019 Year 10 Month 10 Day
Date trial data considered complete	2019 Year 10 Month 10 Day
Date analysis concluded	2019 Year 10 Month 11 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 16 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024777