UMIN-CTR Clinical Trial

Public title

Changes in Attention Function in MCI Patients Based on Different Evaluation Spaces - Training tasks that incorporate projection technology and artistic elements -

Acronym

Changes in Attention Function in MCI Patients Based on Different Evaluation Spaces - Training tasks that incorporate projection technology and artistic elements -

Scientific Title

Changes in Attention Function in MCI Patients Based on Different Evaluation Spaces - Training tasks that incorporate projection technology and artistic elements -

Scientific Title:Acronym

Changes in Attention Function in MCI Patients Based on Different Evaluation Spaces - Training tasks that incorporate projection technology and artistic elements -

Region

Japan

Condition

Mild Cognitive Impairment

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The Trail Making Test (TMT), the most basic evaluation method for attention disorders, is a desk-based test in which simple numbers and hiragana are randomly placed on an evaluation sheet and connected in sequence with a pencil. On the other hand, it has been pointed out that it is difficult to predict impairment in real life based on desk testing alone, and has low ecological validity, because in real life situations, movements are often performed over a wider range of visual fields than those tested on the desk.
Occupational therapy sometimes uses artistic elements, and there have been reports of music-motor therapy for disorders of consciousness and picture erasure tasks for the WISC-IV. However, while artistic elements are a means of facilitating visual stimulation, TMT used for attention disorders involves repetition using simple numbers and hiragana, and current training for attention disorders does not include artistic elements. In this study, we identified the errors and tendencies of examinees during higher brain function assessment, and hypothesized that incorporating an artistic perspective in training and changing the task content to visually and unconsciously direct attention may lead to improved processing time and increased motivation to engage in the task.
The purpose of the present study was to examine whether the addition of an artistic element to attentional training in a large space as a means of stimulating the examinees' visual stimulation would change their processing time and responses compared to the conventional method.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Phase1:Pilot Study
Higher brain dysfunction testing on a conventional desk (desk test) and on a wide screen that is generalized to real-life situations (wide-area projection test) to verify whether equivalent results can be obtained.
Desk-top test: Using the TMT as a reference, create an attention task by placing numbers and hiragana on an A4 sized evaluation sheet.
Part A (TMT-A): Participants are required to connect the numbers from 1 to 25 without releasing their pencils from the randomly placed numbers.
PartB (TMT-B): The participants are required to connect numbers and syllables alternating between numbers and syllables without releasing their pencils.
Extensive display test:
The evaluation form is displayed on a large touch display.
Phase 2: The subject is trained in a wide projection space by adding artistic elements such as paintings and illustrations to the attention function training as a means of stimulating visual stimuli, to verify whether there is a change in the time and response of the subject compared to the conventional method.(Single case design (A1-B-A2 method)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Two methods of testing for attention disorders will be conducted, one on a desk and the other on a large panel.

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

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Those who are 65 years of age or older at the time consent is obtained.
2.Those who meet the following criteria for mild dementia: MMSE-J score of 24 to 27 and MoCA-J score of 25 or less.
3.Those who meet the following criteria: Independent in activities of daily living; walking ability of 12.5 seconds or less/10 m.
4.Standing position retention more than 5 min; FRT test more than 18.5 cm, able to reach forward in a standing position.
5.Those who have obtained written consent to participate in the study.

Key exclusion criteria

Those who are deemed unsuitable by the Principal Investigator or the Principal Investigator.

Target sample size

60

Name of lead principal investigator

1st name	Tomoko
Middle name
Last name	Sakai

Organization

Institute of Science, Tokyo

Division name

Department of Rehabilitation Medicine

Zip code

1128519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

0358035648

Email

t_sakai.orth@tmd.ac.jp

Name of contact person

1st name	Tomoko
Middle name
Last name	Sakai

Organization

Institute of Science Tokyo

Division name

The Department of Rehabilitation Medicine

Zip code

1128519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

03

Homepage URL

Email

t_sakai.orth@tmd.ac.jp

Institute

Institute of Science, Tokyo

Institute

Department

Personal name

Organization

Institute of Science, Tokyo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee of Institute of Science, Tokyo

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-4547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

01

Month

06

Day

Date of IRB

Anticipated trial start date

2025

Year

01

Month

31

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

01

Month

07

Day

Last modified on

2025

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064745