UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043884 |
|---|---|
| Receipt number | R000050109 |
| Scientific Title | A study of metacognitive abilities in patients after traumatic brain injury |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2022/04/11 09:12:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ot-k-yoshida@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050109
