UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045130
Receipt number R000051133
Scientific Title Increase of motor learning capacity by modulating interaction between modules of neural network.
Date of disclosure of the study information 2021/08/30
Last modified on 2024/01/19 16:34:01

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Basic information

Public title

Increase of motor learning capacity by modulating interaction between modules of neural network.

Acronym

Relationship between motor learning capacity and neural network.

Scientific Title

Increase of motor learning capacity by modulating interaction between modules of neural network.

Scientific Title:Acronym

Relationship between motor learning capacity and neural network.

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of transcranial electrical stimulation to modules of neural network on motor learning

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

changes of motor learning ability and brain function

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

10Hz-transcranial alternating current stimulation(10min)

Interventions/Control_2

20Hz-transcranial alternating current stimulation(10min)

Interventions/Control_3

random noise stimulation(10min)

Interventions/Control_4

sham stimulation

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

right handed
normal visual and auditory functions

Key exclusion criteria

history of neurological and psychiatric disorders
claustrophobia
person who has a tattoo
patients with pacemaker in their heart
person with metallic device such as bolt and implant in their body

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hisato
Middle name
Last name Sugata

Organization

Oita University

Division name

Faculty of Welfare and Health Science

Zip code

870-1192

Address

700, Dannoharu, Oita-City, Oita

TEL

097-554-7671

Email

hsugata@oita-u.ac.jp


Public contact

Name of contact person

1st name Hisato
Middle name
Last name Sugata

Organization

Oita University

Division name

Faculty of Welfare and Health Science

Zip code

870-1192

Address

700, Dannoharu, Oita-City, Oita

TEL

097-554-7671

Homepage URL


Email

hsugata@oita-u.ac.jp


Sponsor or person

Institute

Oita University

Institute

Department

Personal name



Funding Source

Organization

Oita University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Oita University

Address

700, Dannoharu, Oita-City, Oita

Tel

097-586-5157

Email

rinrikenkyu@oita-u.ac.jp


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

2021 Year 08 Month 30 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

Open public recruiting

Date of protocol fixation

2021 Year 07 Month 01 Day

Date of IRB

2021 Year 08 Month 30 Day

Anticipated trial start date

2021 Year 08 Month 30 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 08 Month 12 Day

Last modified on

2024 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051133