UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between biological data acquired by wearable device and brain function on neurological patients
Acronym	Relationship between biological data acquired by wearable device and brain function
Scientific Title	Relationship between biological data acquired by wearable device and brain function on neurological patients
Scientific Title:Acronym	Relationship between biological data acquired by wearable device and brain function
Region	Japan

Condition
Condition	neurological diseases
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study,e monitor the biological information of neurological patients continuously using a wearable device, and evaluate the relationships between changes of the biological data and cognitive functions and brain structures after treatments or invasive examinations. Furthermore, we try to establish new evaluation system on patient's ADL/QOL by assessing the chronological changes of biological data detected by the wearable device through admission, treatment and rehabilitation.
Basic objectives2	Others
Basic objectives -Others	Evaluation of physical activity, sleep pattern, amount of conversation, skin temperature, MMSE, change of the brain structures, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amount of change of data acquired by wearable device during 2 weeks
Key secondary outcomes	physical activity, sleep pattern, amount of conversation, skin temperature, MMSE, change of the brain structures

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who will be hospitalized in departments of neurosurgery or neurology and can wear a wearable sensor.
Key exclusion criteria	Patients who can't wear the device because of problems of the hand joint or skin.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasunori Middle name Last name Fujimoto
Organization	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name	Department of Neurosurgery
Zip code	591-8025
Address	1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
TEL	072-252-3651
Email	yfujimoto@osakah.johas.go.jp

Public contact
Name of contact person	1st name Yasunori Middle name Last name Fujimoto
Organization	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Division name	Department of Neurosurgery
Zip code	591-8025
Address	1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
TEL	072-252-3651
Homepage URL
Email	yfujimoto@osakah.johas.go.jp

Sponsor
Institute	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Institute
Department

Funding Source
Organization	Japan Organization of Occupational Health and Safety
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	Japan Organization of Occupational Health and Safety Osaka Rosai Hospital
Address	1179-3, Nagasone-cho, Kita-ku, Sakai, Osaka
Tel	072-252-3651
Email	072-252-3651

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	独立行政法人　労働者健康安全機構　大阪労災病院（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 19 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	50
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	Terminated
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 04 Month 01 Day
Anticipated trial start date	2020 Year 05 Month 11 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information	NA

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2022 Year 11 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045310