UMIN-CTR Clinical Trial

Basic information
Public title	Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Acronym	Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Scientific Title	Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Scientific Title:Acronym	Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
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 effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of correct answers of mental arithmetic.
Key secondary outcomes	Cerebral blood flow in the prefrontal cortex

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Control
Interventions/Control_2	acupuncture
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	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
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 12 Month 01 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	Completed
Date of protocol fixation	2019 Year 08 Month 30 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 11 Day
Last follow-up date	2019 Year 11 Month 29 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 10 Month 08 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043586