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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036312
Receipt No. 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 2019/03/27

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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
Autonomic nervous system function by measuring heart rate variability (HRV)

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 8
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Control
Interventions/Control_2 2Hz, Low intensity
Interventions/Control_3 2Hz, Medium intensity
Interventions/Control_4 2Hz, High intensity
Interventions/Control_5 Control
Interventions/Control_6 100Hz, Low intensity
Interventions/Control_7 100Hz, Medium intensity
Interventions/Control_8 100Hz, High intensity
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 80

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 s.tky0706@gmail.com

Public contact
Name of contact person
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
Homepage URL
Email s.tky0706@gmail.com

Sponsor
Institute Teikyo Heisei University
Institute
Department

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
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
2019 Year 01 Month 08 Day
Date of IRB
2019 Year 02 Month 25 Day
Anticipated trial start date
2019 Year 02 Month 25 Day
Last follow-up date
2019 Year 07 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 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.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


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