UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of cognitive training using eye movements on neural systems and cognitive functions.
Title of the study (Brief title)	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	Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Advanced Brain Science
Address	4-1, Seiryo-machi, Aoba-ku, Sendai-shi
TEL	022-717-9887
Email	ryuta@tohoku.ac.jp

Public contact
Name of contact person	Toshiki Saito
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Advanced Brain Science
Address	4-1, Seiryo-machi, Aoba-ku, Sendai-shi
TEL	022-717-9887
Homepage URL
Email	toshiki.saito@med.tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033049