UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030362 |
|---|---|
| Receipt number | R000034667 |
| Scientific Title | Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease |
| Date of disclosure of the study information | 2017/12/12 |
| Last modified on | 2020/02/17 14:57:02 |
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Basic information
Public title
Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Acronym
Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Scientific Title
Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Scientific Title:Acronym
Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Region
| Japan |
Condition
Condition
moyamoya disease
Classification by specialty
| Radiology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in neuropsychological test performance, and the morphological and functional changes of the brain, following neurocognitive training in moyamoya disease patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of correct answers in the PASAT score before and after the neurocognitive training and the magnitude of change in the scores
Key secondary outcomes
1.Pre- and post-neurocognitive training neuropsychological test results (trail making test part A and B, digit span test, tapping span test, standard verbal paired-associate learning test scores)and the magnitude of change
2.Pre- and post-training morphological and functional imaging results and the magnitude of change
3.Correlation between the morphological and functional imaging results and the neuropsychological performance (the magnitude of change in each score before and after training)
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Neurocognitive training
1 hour/session, 5 sessions/week for 4 weeks, a total of 20 hours
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients between 20 and 65 years of age at the time of consent
2.Those who were diagnosed as moyamoya disease according to the guidelines of MMD proposed by the Research Committee on spontaneous occlusion of the circle of Willis
3.Those patients who gave informed consent based on own will or the will of a guardian
Key exclusion criteria
1.Quasimoyamoya syndrome with conditions such as Down syndrome and neurofibromatosis
2.Stroke with neurological deficit
3.Psychological or neurological disorders which affect the neuropsychological test performance
4.Vision or hearing impairment or motor disability which affects the neuropsychological test performance
5.Contraindications for MRI (cardiac pacemaker, inner ear implant, claustrophobia, etc)
6.Revascularization surgery before the study
7.Conditions in which the principal investigator considers not suitable for participation in the study
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Khin Khin |
| Middle name | |
| Last name | Tha |
Organization
Hokkaido University Hospital
Division name
Department of diagnostic and interventional radiology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-ku, Sapporo
TEL
011-706-5977
kktha@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Hokkaido University
Division name
Graduate School of Biomedical Science and Engineering
Zip code
060-0812
Address
Kita14, Nishi5, Kita-ku, Sapporo
TEL
011-706-8183
Homepage URL
dai-sawa@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital,
Department of diagnostic and interventional radiology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital,
Department of diagnostic and interventional radiology
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
Institutional Review Board of Hokkaido University Hospital
Address
kita-14, nishi-5, Kita-ku
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2017 | Year | 12 | Month | 12 | 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
| 2017 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034667
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| Registered date | File name |
| Research case data | |
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