UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032037 |
|---|---|
| Receipt number | 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 | 2021/04/01 18:17:15 |
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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
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
motoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036553
