UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028889
Receipt number R000033049
Scientific Title The effect of cognitive training using eye movements on neural systems and cognitive functions.
Date of disclosure of the study information 2017/08/31
Last modified on 2017/09/01 09:20:39

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Basic information

Public title

The effect of cognitive training using eye movements on neural systems and cognitive functions.

Acronym

Cognitive training using eye movements

Scientific Title

The effect of cognitive training using eye movements on neural systems and cognitive functions.

Scientific Title:Acronym

Cognitive training using eye movements

Region

Japan North America


Condition

Condition

healthy young and older adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the beneficial effects of cognitive training using eye movements on cognitive function and neural systems.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Go/No-Go Task

Key secondary outcomes

Antisaccade Task
Verbal fluency task (VFT)
Digit Span Forward (DS-F)
Digit span Backward (DS-B)
Japanese Reading Test (JART)
Digit Cancellation Task (D-CAT)
Digit Symbol Coding (Cd)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The cognitive intervention group participate in Antisaccade task and Prosaccade task for 4 weeks.

Interventions/Control_2

The control group participate in only Prosaccade task for 4 weeks.

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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy young and older adults who will report to be right-handed, native Japanese speakers, not using medications known to interfere with cognitive functions (including benzodiazepines, antidepressants or other central nervous agents), and having no diseases known to affect the central nervous system, including thyroid disease, multiple sclerosis, Parkinson's disease, stroke, severe hypertension or diabetes.

Key exclusion criteria

Person who is concerned about their own memory functions.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Advanced Brain Science

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai-shi

TEL

022-717-9887

Email

ryuta@tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiki Saito

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Advanced Brain Science

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai-shi

TEL

022-717-9887

Homepage URL


Email

toshiki.saito@med.tohoku.ac.jp


Sponsor or person

Institute

Institute of Development, Aging and Cancer, Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 08 Month 31 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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 29 Day

Last modified on

2017 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name