UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study of the visual function training for application to developmental dyslexia.
Title of the study (Brief title)	visual function training
Region	Japan

Condition
Condition	normal adult
Classification by specialty	Pediatrics Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The dysfunction of reading and writing in developmental dyslexia were suspected to be due to visual function. We investigated that effect of training on visual function in normal adults, using event-related brain potential (ERP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The amount of change of the ERP amplitude before and after the training.
Key secondary outcomes	The number of the correct answers of memory and attentional task(digit span, visual memory task, reading span task, visual attention span, and reading aloud test) before and after the training. The number of the correct answers in training performance.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	visual attention training (25 days)
Interventions/Control_2	visual working memory training (25 days)
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	29 years-old >=
Gender	Male and Female
Key inclusion criteria	The person that we can examine it in Hokkaido University and training of 25th is possible without rest period more than two days. The person who agreed to a participation after informed an adequate explanation for the study.
Key exclusion criteria	The person who has received a diagnosis of theNeurodevelopmental Disorders in DSM-5 until now. The person whom experimenter judged to be inappropriate as a participant.
Target sample size	24

Research contact person
Name of lead principal investigator	Yukio TSCUHIDA
Organization	Graduate school of medicine, University of the Ryukyus
Division name	Department of Neurosurgery
Address	207, Uehara Nishihara-cho, Okinawa 903-0215, Japan
TEL	098-895-1171
Email	tsuchida@mail.ryudai.jp

Public contact
Name of contact person	Yukio TSUCHIDA
Organization	Graduate school of medicine, University of the Ryukyus
Division name	Department of Neurosurgery
Address	207, Uehara Nishihara-cho, Okinawa 903-0215, Japan
TEL	098-895-1171
Homepage URL
Email	tsuchida@mail.ryudai.jp

Sponsor
Institute	Graduate school of medicine, University of the Ryukyus Department of Neurosurgery
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology. Japan society for the promotion of science.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Graduate School of Education, Hokkaido University
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	北海道大学大学院教育学研究院

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 11 Month 16 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	There was no general effect on visual working memory (WM) and visual attention (VA) span training. In the results of event related potentials, it was suggested that WM training, rather than VA span, improved early selective attention. This study suggests that WM training is more effective than VA span, but its effect may be limited.
Other related information

Management information
Registered date	2016 Year 11 Month 04 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028435