臨床研究等提出・公開システム

Date of registration	May. 23, 2025
Last modified on	Dec. 08, 2025
Trial ID	jRCT1032250122

Scientific Title	Evaluation of Cerebral Circulation Using the Near-Infrared Spectroscopy Device NIRO-Pulse: A Multi-Center Prospective Observational Study (NIRO-Pulse Cerebral Circulation Evaluation Study)
Public Title	Evaluation of Cerebral Circulation in Healthy Individuals Using the Near-Infrared Spectroscopy Device : A Multi-Center Prospective Observational Study (NIRO Cerebral Circulation Evaluation Study)

Contact for Scientific Queries	Name	Marushima Aiki
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba
	Telephone	+81-29-853-3220
	E-mail	aiki.marushima@md.tsukuba.ac.jp
Contact for Public Queries	Name	Marushima Aiki
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba
	Telephone	+81-29-853-3220
	E-mail	aiki.marushima@md.tsukuba.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		May. 23, 2025
Target sample size		60
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Individuals who underwent a brain dock at the Tsukuba Preventive Medicine Research Center of the University of Tsukuba Hospital.
	Exclusion Criteria	1. Individuals for whom NIRS could not be applied for any reason. 2. Individuals who did not consent to participate as volunteers or who withdrew their consent.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		none
Health Condition(s) Keyword		NIRS
Primary Outcome(s)		Cerebral blood flow asymmetry
Secondary Outcome(s)		Various parameters obtained from devices, personal data obtained from medical records (blood collection tests, imaging tests)

Primary Sponsor	Hamamatsu Photonics

Name of Certified Review Board	the Clinical Research Ethics Review Committee of the University of Tsukuba Hospital
Address	1-1-1 tennodai, amakubo,Tsukuba , Ibaraki
Telephone	+81-29-853-3749
E-Mail	tcr.nintei@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	July. 26, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 08, 2025	(this page)	Changes
1	May. 23, 2025	Detail

List of change history