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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032037
Receipt No. R000036553
Scientific Title Effectiveness of Cognitive Training on the patients' white matter with mild cognitive impairment evaluated by brain imaging analysis
Date of disclosure of the study information 2018/03/31
Last modified on 2020/04/01

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Basic information
Public title Effectiveness of Cognitive Training on the patients' white matter with mild cognitive impairment evaluated by brain imaging analysis
Acronym Effectiveness of cognitive training by brain MR diffusion imaging
Scientific Title Effectiveness of Cognitive Training on the patients' white matter with mild cognitive impairment evaluated by brain imaging analysis
Scientific Title:Acronym Effectiveness of cognitive training by brain MR diffusion imaging
Region
Japan

Condition
Condition Mild cognitive impairement
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the usefulness of home-based cognitive training using diffusion MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neuropsychological tests before and after brain training for 12 weeks
Key secondary outcomes Diffusion MRI before and after brain training for 12 weeks

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 home-based brain training which includes dual task, reading and writing for 12 weeks.3 times a week Each session is 1 hour.
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
50 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who have subjective and objective memory impairments.
2. Patients who scored from 23 to 26 on MMSE.
3. Outpatients
4. Patients who live with family members or others
Key exclusion criteria 1. Patients with alcoholics
2. Patients with epilepsy
3. patients whose educational history is less than 6 years.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yumiko
Middle name
Last name Motoi
Organization Juntendo University School of Medicine
Division name Department of Diagnosis, Prevention and Treatment of Dementia
Zip code 1130033
Address Hongo 2-1-1 Bunkyo-ku Tokyo
TEL 03-3813-3111
Email motoi@juntendo.ac.jp

Public contact
Name of contact person
1st name Yumiko
Middle name
Last name Motoi
Organization Juntendo University School of Medicine
Division name Department of Diagnosis, Prevention, and Treatment of Dementia
Zip code 1130033
Address Hongo 2-1-1 Bunkyo-ku Tokyo
TEL 03-3813-3111
Homepage URL
Email motoi@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo University School of Medicine
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 Juntendo University School of Medicine
Address Hongo 2-1-1 Bunkyo ku Tokyo
Tel 0338133111
Email motoi@juntendo.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
2018 Year 03 Month 31 Day

Related information
URL releasing protocol https://www.abstractsonline.com/pp8/#!/7883/presentations/MCI,%20Hattori,%20Motoi,%20cognitive%20tra
Publication of results Unpublished

Result
URL related to results and publications https://www.abstractsonline.com/pp8/#!/7883/presentations/MCI,%20Hattori,%20Motoi,%20cognitive%20tra
Number of participants that the trial has enrolled 17
Results
The scores of digit span and Logical Memory I were significantly improved . The cortical thicknesses of the left supplementary motor area(SMA), the left superior frontal gyrus (L-SFG), frontal pole (FP) and orbitofrontal cortex(OFC) were negatively correlated with the score of digit span total points (DS), forward (DSF) and backward (DSB).
Results date posted
2020 Year 02 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
MCI patients The average age is 78.65 years old, the years of education on average is 12.53 years.
Participant flow
patients with MCI were instructed to perform training exercises three times per week for 12 weeks at home accompanied with their caretakers. The training includes two-digit number calculation, reading a short original story, fill-in-the blank tasks, simple calculations and dual task training. The caretakers measured the time spent in all tasks, and they took around 40 minutes on average. MRI and 13 neuropsychological tests were undertaken before and after the training. 
Adverse events
None
Outcome measures
# the alteration in surface-based morphometry (SBM)
# neuropsychological tests
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 31 Day
Date of IRB
2018 Year 03 Month 22 Day
Anticipated trial start date
2018 Year 03 Month 31 Day
Last follow-up date
2019 Year 01 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
2018 Year 03 Month 31 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036553

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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