UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036312
Receipt number R000041362
Scientific Title Examination of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.
Date of disclosure of the study information 2019/03/27
Last modified on 2019/10/08 15:00:44

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Basic information

Public title

Examination of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.

Acronym

Examination of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.

Scientific Title

Examination of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.

Scientific Title:Acronym

Examination of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effect of optimum intensity when acupuncture stimulation intervention to the head exerts on the cerebral blood flow in the prefrontal cortex.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral blood flow in the prefrontal cortex

Key secondary outcomes

Heart rate


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Control

Interventions/Control_2

100Hz, 0.1mA

Interventions/Control_3

100Hz, 0.2mA

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

16 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

Men and women over 16 years of age.
Those who can attend the research site during the research period.
Those who can obtain written consent for participation in this research.
Those who have not participated in other experiments within 3 months.

Key exclusion criteria

Patients who are outpatients or taking medications for underlying diseases (diabetes, heart disease, kidney disease, liver disease, hyponatremia, hypertension that is difficult to treat, etc.).
Person receiving medication.
Those with extremely short sleep (less than 5 hours a day) and those with long sleep (more than 10 hours a day).
Those who have reversed day and night due to work or part-time work.
Person who receives excessive physical and mental stress.
Persons who are treated for autoimmune disease, chronic inflammatory disease, allergic disease, and cancer.
Those who practice excessive smoking and excessive alcohol consumption and those whose diet is extremely irregular.
Person with remarkable abnormality by blood pressure, blood test, urine test.
Those who performed 400 ml blood donation within 12 weeks of the experiment start, 200 ml blood donation within 4 weeks, and the component blood donation within 2 weeks.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tatsuya
Middle name
Last name Hisajima

Organization

Teikyo Heisei University

Division name

Faculty of Health Care

Zip code

170-8445

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo

TEL

03-5843-4860

Email

hisajimatatsuya@mac.com


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Suzuki

Organization

Teikyo Heisei University

Division name

Graduate School of Health Sciences

Zip code

170-8445

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo

TEL

03-5843-4860

Homepage URL


Email

s.tky0706@gmail.com


Sponsor or person

Institute

Teikyo Heisei University

Institute

Department

Personal name



Funding Source

Organization

Teikyo Heisei 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

Teikyo Heisei University

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo

Tel

03-5843-4860

Email

s.tky0706@gmail.com


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 03 Month 27 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

12

Results

EA stimulation at 0.2 mA was associated with greater OxyHb levels in the PFC at Ch 4, 10, 12, and 13 than the 0.1 mA condition. Compared with the control condition, 0.2 mA EA was associated with greater OxyHb levels at Ch 2-6, 10, and 12-14, and greater TotalHb levels at Ch 3, 4, 6, and 12-14.

Results date posted

2019 Year 08 Month 26 Day

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

Completed

Date of protocol fixation

2019 Year 01 Month 08 Day

Date of IRB

2019 Year 02 Month 25 Day

Anticipated trial start date

2019 Year 03 Month 27 Day

Last follow-up date

2019 Year 06 Month 28 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 03 Month 27 Day

Last modified on

2019 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041362


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name