UMIN-CTR Clinical Trial

Basic information
Public title	Investigating the brain regions associated with Sense of Agency recognition
Acronym	Investigating the brain regions associated with Sense of Agency recognition
Scientific Title	Investigating the brain regions associated with Sense of Agency recognition
Scientific Title:Acronym	Investigating the brain regions associated with Sense of Agency recognition
Region	Japan

Condition
Condition	Chronic Pain
Classification by specialty	Anesthesiology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Using electroencephalography (EEG) to determine if there are characteristics of the EEG associated with sense of agency recognition in healthy subjects and chronic pain patients, and if there is a difference between the two
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG, questionnaire on the degree of SoA recognition, and questionnaire on the degree of pain
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	We ask the subject to move his or her arms while feeling the Sense of Agnecy, and measure the EEG during the movement.
Interventions/Control_2	We ask the subject to move his or her arms while not feeling the Sense of Agency, and measure the EEG during that time.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients are required to meet the following conditions: 1.consenting to voluntary participation of the study with consent form 2.suffering from refractory chronic pain, such as neuropathic pain 3.attending the pain clinic at Kawasaki Medical School Hospital. (2)Healthy people are required to meet the following conditions: 1.consesting to voluntary participation of the study with consent form 2.over 20 years old
Key exclusion criteria	(1)Patients who are unable to operate information input devices from some reasons, such as severe pain or motor disturbance, are excluded. (2)There is no key exclusion criteria for healthy people
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Gofuku
Organization	Okayama University
Division name	Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code	7008530
Address	#408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,Kita-ku,Okayama-shi,Okayama,700-8530,Japan
TEL	086-251-8022
Email	fukuchan@sys.okayama-u.ac.jp

Public contact
Name of contact person	1st name Akio Middle name Last name Gofuku
Organization	Okayama University
Division name	Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code	7008530
Address	#408 Studies of Natural Science and Technology,3-1-1, Tsushimanaka, Kita-ku, Okayama-shi, Okayama, J
TEL	086-251-8022
Homepage URL
Email	fukuchan@sys.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Ministry of education and Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University
Address	#408 Studies of Natural Science and Technology,3-1-1, Tsushimanaka, Kita-ku, Okayama-shi, Okayama, Japan
Tel	086-251-8022
Email	fukuchan@sys.okayama-u.ac.jp

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	2020 Year 11 Month 11 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 12 Day
Date of IRB	2020 Year 10 Month 27 Day
Anticipated trial start date	2020 Year 10 Month 28 Day
Last follow-up date	2023 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	2020 Year 11 Month 04 Day
Last modified on	2020 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047407