UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051039
Receipt number R000058190
Scientific Title The effects of transcranial alternating current stimulation on spatial attention
Date of disclosure of the study information 2023/05/11
Last modified on 2023/12/11 16:24:08

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Basic information

Public title

The effects of transcranial alternating current stimulation on spatial attention

Acronym

The effects of transcranial alternating current stimulation on spatial attention

Scientific Title

The effects of transcranial alternating current stimulation on spatial attention

Scientific Title:Acronym

The effects of transcranial alternating current stimulation on spatial attention

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to determine the effects of transcranial alternating current stimulation on spatial attention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reaction time

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

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Conditions for intervening transcranial alternating current stimulation in the alpha band (in-phase stimulation, Anti-phase stimulation, sham stimulation).

Interventions/Control_2

Conditions for intervening transcranial alternating current stimulation in the gamma band (in-phase stimulation, Anti-phase stimulation, sham stimulation).

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Persons who have seen the e-mail recruiting experimental subjects and who voluntarily wished to participate in the experiment.

Key exclusion criteria

Exclusion criteria are pregnant women, patients on dialysis, taking neuro-active drugs, having metal or electronic devices in the body, previous epileptic seizures, nerve damage, skin disease at the location of electrode application, and previous orthopedic disease in the hand.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kyosuke
Middle name
Last name Shiga

Organization

Graduate School, Niigata University of Health and Welfare

Division name

Institute for Human Movement and Medical Sciences

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

TEL

025-257-4445

Email

hpm22008@nuhw.ac.jp


Public contact

Name of contact person

1st name Kyosuke
Middle name
Last name Shiga

Organization

Graduate School, Niigata University of Health and Welfare

Division name

Institute for Human Movement and Medical Sciences

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

TEL

025-257-4445

Homepage URL


Email

hpm22008@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Health and Welfare

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

Niigata University of Health and Welfare

Address

1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

Tel

025-257-4455

Email

rinri@nuhw.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

2023 Year 05 Month 11 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

2023 Year 03 Month 10 Day

Date of IRB

2023 Year 05 Month 12 Day

Anticipated trial start date

2023 Year 04 Month 07 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2023 Year 05 Month 11 Day

Last modified on

2023 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058190


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name