UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037582
Receipt number R000042758
Scientific Title Effects of transcranial Alternating Current Stimulation (tACS) on activation of anterior cingulate cortex and behavior of healthy young
Date of disclosure of the study information 2019/08/02
Last modified on 2020/02/28 19:30:08

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Basic information

Public title

Effects of transcranial Alternating Current Stimulation (tACS) on activation of anterior cingulate cortex and behavior of healthy young

Acronym

ETACS2

Scientific Title

Effects of transcranial Alternating Current Stimulation (tACS) on activation of anterior cingulate cortex and behavior of healthy young

Scientific Title:Acronym

ETACS2

Region

Japan


Condition

Condition

normal adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effects of 6Hz-tACS on activity of anterior cingulate cortex and behavioral performance.

Basic objectives2

Others

Basic objectives -Others

n.a.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Activity of anterior cingulate cortex and behavioral performance.

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

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

6Hz tACS

Interventions/Control_2

30Hz tACS

Interventions/Control_3

sham tACS

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) 20 years old or more
2) right handedness
3) no history of neurological and psychiatric disease
4) Applicable MRI test
5) Informed consent

Key exclusion criteria

n.a.

Target sample size

69


Research contact person

Name of lead principal investigator

1st name Keiichi
Middle name
Last name Onoda

Organization

Shimane University

Division name

Department of Medicine

Zip code

693-8501

Address

89-1, Enyacho, Izumo, Shimane

TEL

0853-20-2343

Email

onodak1@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Keiichi
Middle name
Last name Onoda

Organization

Shimane University

Division name

Department of Medicine

Zip code

693-8501

Address

89-1, Enyacho, Izumo, Shimane

TEL

0853-20-2343

Homepage URL


Email

onodak1@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University

Institute

Department

Personal name



Funding Source

Organization

Shimane University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Shimane University

Address

89-1, Enyacho, Izumo, Shimane

Tel

0853-20-2515

Email

kenkyu@med.shimane-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

2019 Year 08 Month 02 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

Terminated

Date of protocol fixation

2019 Year 06 Month 20 Day

Date of IRB

2019 Year 07 Month 22 Day

Anticipated trial start date

2019 Year 08 Month 11 Day

Last follow-up date

2020 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

2019 Year 08 Month 02 Day

Last modified on

2020 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name