UMIN-CTR Clinical Trial

Basic information
Public title	A study of metacognitive abilities in patients after traumatic brain injury
Acronym	A study of metacognitive abilities in patients after traumatic brain injury
Scientific Title	A study of metacognitive abilities in patients after traumatic brain injury
Scientific Title:Acronym	A study of metacognitive abilities in patients after traumatic brain injury
Region	Japan

Condition
Condition	traumatic brain injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of the study is to evaluate metacognitive ability in patients after traumatic brain injury by using a behavioral task. We also examine whether patients' cognitive ability and brain legions are associated with their metacognitive ability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy rate and reaction time of the behavioral task for evaluating patient's metacognitive ability.
Key secondary outcomes	Paced auditory serial addition test: PASAT Symbol digit modalities test: SDMT Rey's verbal learning test: RAVLT Wisconsin card sorting test: WCST Patient Competency Rating Scale: PCRS Frontal Systems Behavior Scale: FrSBe The magnetic resonance images including T1, T2, and FLAIR

Base
Study type	Others,meta-analysis etc

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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients between 20 and 60 years old at the time of consent. 2.Those who were diagnosed with traumatic brain injury and were at least over 3 months post-injury. 3.Those patients who gave informed consent based on their own will or the will of a guardian.
Key exclusion criteria	1.Patients who had a history of psychiatric or neurological disorders prior to the diagnosis of traumatic brain injury. 2.Patients who have difficulty performing the behavioral task or neurological test due to severe motor paralysis, aphasia, vision, or hearing impairment, etc. 3.Conditions in which the principal investigator considers not suitable for participation in the study.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Katsunori Middle name Last name Ikoma
Organization	Hokkaido University Hospital
Division name	Department of Rehabilitation Medicine
Zip code	060-8648
Address	N14 W5, Kita-ku, Sapporo
TEL	011-706-6066
Email	ikoma@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Kazuki Middle name Last name Yoshida
Organization	Hokkaido University
Division name	Department of Health Sciences
Zip code	060-0812
Address	N12 W5, Kita-ku, Sapporo
TEL	011-706-3414
Homepage URL
Email	ot-k-yoshida@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Hokkaido University Hospital
Address	N14 W5, Kita-ku, Sapporo
Tel	011-706-6066
Email	ot-k-yoshida@huhp.hokudai.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	2021 Year 12 Month 31 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	28
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	2020 Year 04 Month 27 Day
Date of IRB	2020 Year 04 Month 27 Day
Anticipated trial start date	2021 Year 04 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	Data correction has been completed and is currently being analyzed.

Management information
Registered date	2021 Year 04 Month 10 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050109