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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042346
Receipt No. R000047407
Scientific Title Investigating the brain regions associated with Sense of Agency recognition
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/04

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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