UMIN-CTR Clinical Trial

Basic information
Public title	The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Acronym	The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Scientific Title	The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Scientific Title:Acronym	The influences of active and passive activation on cerebral blood flow and motor performances during finger motions
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider impact of active and passive brain activation on cerebral blood flow and finger exercise performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of oxyhemoglobin during motor task
Key secondary outcomes	Motor peformances(the number of motor task, the successful number of motor task, error ration of motor task, smoothness of hand during motor task)

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	6
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Visit1:Motor task, Control(rest;2 minutes), Motor task interval(at least a day) Visit2: Motor task, Simple hand grasping exercise(2 minutes), Motor task interval(at least a day) Visit3: Motor task, Transcranial direct current stimulation(15 minutes), Motor task
Interventions/Control_2	Visit1: Motor task, Control(rest;2 minutes), Motor task interval(at least a day) Visit2: Motor task, Transcranial direct current stimulation(15 minutes), Motor task interval(at least five days) Visit3: Motor task, Simple hand grasping exercise(2 minutes), Motor task
Interventions/Control_3	Visit1: Motor task, Simple hand grasping exercise(2 minutes), Motor task interval (at least a day) Visit2: Motor task, Control(rest;2 minutes), Motor task interval (at least a day) Visit3:Motor task, Transcranial direct current stimulation(15 minutes), Motor task
Interventions/Control_4	Visit1: Motor task, Simple hand grasping exercise(2 minutes), Motor task interval (at least a day) Visit2: Motor task, Transcranial direct current stimulation(15 minutes), Motor task interval (at least five days) Visit3: Motor task, Control(rest;2 minutes), Motor task
Interventions/Control_5	Visit1: Motor task, Transcranial direct current stimulation(15 minutes), Motor task interval (at least five days) Visit2: Motor task, Control(rest;2 minutes), Motor task interval (at least a day) Visit3: Motor task, Simple hand grasping exercise(2 minutes), Motor task
Interventions/Control_6	Visit1: Motor task, Transcranial direct current stimulation(15 minutes), Motor task interval (at least five days) Visit2: Motor task, Simple hand grasping exercise(2 minutes), Motor task interval (at least a day) Visit3: Motor task, Control(rest;2 minutes), Motor task
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	The dominant hand is right-handed. Who consent is obtained in writing with respect to the participation of research.
Key exclusion criteria	There is a history of neurological disorders, psychiatric disorders. There is a history or current medical history of impaired cognitive function. There is musculoskeletal disorders of the hand finger.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Sunagawa
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Analysis & Control of Upper Extremity Function
Zip code
Address	1-2-3 Kasumi Hiroshima Japan
TEL	082-257-5455
Email	torusuna@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Onishi
Organization	Hiroshima University Graduate School of Biomedical & Health Sciences
Division name	Analysis & Control of Upper Extremity Function
Zip code
Address	1-2-3 Kasumi Hiroshima Japan
TEL	082-257-5457
Homepage URL
Email	m145422@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Graduate School of Biomedical & Health Sciences, Control of Upper Extremity Function
Institute
Department

Funding Source
Organization	Grants in aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 01 Month 05 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	2015 Year 11 Month 30 Day
Date of IRB	2015 Year 12 Month 14 Day
Anticipated trial start date	2016 Year 01 Month 05 Day
Last follow-up date	2017 Year 03 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	2015 Year 12 Month 30 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023565