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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name