UMIN-CTR Clinical Trial

Basic information
Public title	EEG study of Brain Activities Associated with the Sense of Agency in patients with chronic upper limb pain
Acronym	EEG study of Brain Activities Associated with the Sense of Agency in patients with chronic upper limb pain
Scientific Title	EEG study of Brain Activities Associated with the Sense of Agency in patients with chronic upper limb pain
Scientific Title:Acronym	EEG study of Brain Activities Associated with the Sense of Agency in patients with chronic upper limb pain
Region	Japan

Condition
Condition	patients with chronic upper limb pain
Classification by specialty	Neurology Anesthesiology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	EEG Study is conducted to investigate sense of agency related brain regions in patients with chronic pain
Basic objectives2	Others
Basic objectives -Others	EEG Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sense of agency related brain regions in patients with chronic pain
Key secondary outcomes

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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	patients with chronic upper limb pain
Key exclusion criteria	pain scale (visual analog scale) belows 30/100 chronic pain condition over 3 monthes cognitive dysfunction
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Sato
Organization	kawasaki medical school
Division name	Department of anesthesiology and intensive care medicine 1
Zip code	7010192
Address	577 Matsushima, Kurashiki city, Okayama 701-0192 Japan
TEL	086-462-1111
Email	k.sato@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Sato
Organization	kawasaki medical school
Division name	Department of anesthesiology and intensive care medicine 1
Zip code	7010192
Address	577 Matsushima, Kurashiki city, Okayama 701-0192 Japan
TEL	086-462-1111
Homepage URL
Email	k.sato@med.kawasaki-m.ac.jp

Sponsor
Institute	kawasaki medical school
Institute
Department

Funding Source
Organization	kawasaki medical school
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	kawasaki medical school
Address	577 Matsushima, Kurashiki city, Okayama 701-0192 Japan
Tel	0864621111
Email	kmsrec@med.kawasaki-m.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	2022 Year 09 Month 01 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	2022 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	EEG Study is conducted to investigate sense of agency related brain regions in patients with chronic pain

Management information
Registered date	2022 Year 03 Month 29 Day
Last modified on	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053962