UMIN-CTR Clinical Trial

Public title

Intervention study of the visual function training for application to developmental dyslexia.

Acronym

visual function training

Scientific Title

Intervention study of the visual function training for application to developmental dyslexia.

Scientific Title:Acronym

visual function training

Region

Japan

Condition

normal adult

Classification by specialty

Pediatrics	Psychiatry	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yukio TSCUHIDA

Organization

Graduate school of medicine, University of the Ryukyus

Division name

Department of Neurosurgery

Zip code

Address

207, Uehara Nishihara-cho, Okinawa 903-0215, Japan

TEL

098-895-1171

Email

tsuchida@mail.ryudai.jp

Name of contact person

1st name
Middle name
Last name	Yukio TSUCHIDA

Organization

Graduate school of medicine, University of the Ryukyus

Division name

Department of Neurosurgery

Zip code

Address

207, Uehara Nishihara-cho, Okinawa 903-0215, Japan

TEL

098-895-1171

Homepage URL

Email

tsuchida@mail.ryudai.jp

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Graduate School of Education, Hokkaido University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学大学院教育学研究院

Date of disclosure of the study information

2016

Year

11

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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.

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

2016

Year

11

Month

16

Day

Date of IRB

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

Other related information

Registered date

2016

Year

11

Month

04

Day

Last modified on

2017

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028435