UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021500 |
|---|---|
| Receipt number | R000024777 |
| Scientific Title | The association of stroke in cerebellar with cognitive function |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2020/09/18 10:10:36 |
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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
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
toshiogata@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
