UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Title of the study (Brief title)	Portable non-verification of the effectiveness in muscle blood flow measurement of noninvasive brain oxygen saturation monitor
Region	Japan

Condition
Condition	Healthy adults A patient with diabetes and arteriosclerosis will consider from now on, too.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Portable non-invasive cerebral oxygen saturation monitoring, measurement of muscle blood flow is, and a variation of the biological tissue oxygen saturation and hemoglobin in real time non-invasively be continuously measured invasive where possible. Inadequate accumulation of data, reliability is to detect infrared light irradiation on the human body, and measure changes in the relative concentration of hemoglobin in the blood and oxygen saturation to provide medical information. We use belt electrode skeletal muscle electric stimulation, healthy adults to electrical stimulation in the rehabilitation field very generally used as sinks current only 1 side leg and confirmed differences in blood flow and lower limb-to-HAND ai TOS, to verify the improvement of blood flow.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood flow measurement before and behind the electric stimulus method of treatment is tried. Validate to validate the reliability and validity of the correlation between the thermography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The bloodstream change in the electric stimulus therapy context of 20 minutes is confirmed. Measuring, it itself is about total 30 minutes.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	The one on which a pacemaker loaded the plantation type electrical appliance in the body Something by which the severe past is in a leg Pregnant woman or person with a possibility of the pregnancy
Target sample size	10

Research contact person
Name of lead principal investigator	Takumi Nakashima
Organization	National Center for Global Health and Medicine
Division name	Rehabilitation
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	0332027181
Email	takunakashima@hosp.ncgm.go.jp

Public contact
Name of contact person	Takumi Nakashima
Organization	National Center for Global Health and Medicine
Division name	Rehabilitation
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL	0332027181
Homepage URL
Email	takunakashima@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Own supply
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 15 Day
Last modified on	2017 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026738