UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053441 |
|---|---|
| Receipt number | R000060983 |
| Scientific Title | Study on Brain-derived neurotrophic factor concentrations in Patients with CO 60th year. |
| Date of disclosure of the study information | 2024/01/29 |
| Last modified on | 2025/07/26 11:08:35 |
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Basic information
Public title
Study using BDNF as a Biomarker for Neurocognitive Function in Patients with Carbon Monoxide Poisoning 60 Years after a Dust Explosion
Acronym
COP study 60th year
Scientific Title
Study on Brain-derived neurotrophic factor concentrations in Patients with CO 60th year.
Scientific Title:Acronym
BDNF in COP study 60th year
Region
| Japan |
Condition
Condition
Patients with Carbon Monoxide Poisoning
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the neurocognitive function at the 60-year mark in patients with simultaneous carbon monoxide poisoning due to a dust explosion, using BDNF as a biomarker.
Basic objectives2
Others
Basic objectives -Others
To investigate the sequelae of patients with carbon monoxide poisoning due to a dust explosion as a 60-year follow-up study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain-derived neurotrophic factor (BDNF) concentrations 60 years after the onset of carbon monoxide poisoning.
Key secondary outcomes
Mini Mental State Examination, Trail Making Test
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
| 75 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients with carbon monoxide poisoning by the dust explosion 60 years ago.
OR former miner
Key exclusion criteria
The impossibility that stands alone in everyday life.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Matsuse |
| Middle name | |
| Last name | Hiroo |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Matsuse |
| Middle name | |
| Last name | Hiroo |
Organization
Kurume University
Division name
Rehabilitation center
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942353311
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Grants for Occupational Diseases and Injuries
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
Ethics Committee of Kurume University
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942653749
i_rinri@kurume-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
| 2024 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2666459325000836
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2666459325000836
Number of participants that the trial has enrolled
23
Results
The blood BDNF levels in elderly patients with sequelae of CO poisoning were lower than those in healthy elderly individuals.
Results date posted
| 2024 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Because the paper was accepted later than expected
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 23 | Day |
Baseline Characteristics
The study included 23 participants, all male, with a mean age of 79.3 years. All subjects had chronic neurological sequelae due to carbon monoxide (CO) poisoning sustained approximately 60 years ago during a coal-dust explosion. Baseline assessments included the Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS), Barthel Index, and serum BDNF levels. Most participants demonstrated mild cognitive impairment but retained moderate to high levels of independence in ADLs. All were living in the community, and none required institutional care.
Participant flow
Initially, 27 individuals were approached, and 23 met the inclusion criteria and agreed to participate. All 23 underwent baseline cognitive and physical assessments and blood sampling for BDNF levels. There were no dropouts, and data from all 23 participants were included in the final analysis. The study was cross-sectional, and all data were collected during a single visit.
Adverse events
Non
Outcome measures
Mini Mental State Examination
Trail Making Test A,B
ADL
BDNF
Plan to share IPD
Non
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 01 | Day |
Other
Other related information
An observational study of carbon monoxide poisoning patients from a dust explosion that occurred 60 years ago, comparing them with former coal mine workers who worked in the same mine as a control group.
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060983
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/10/01 | 研究計画書（CO中毒後遺症患者の血中BDNF）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/10/01 | 研究仕様書（CO中毒後遺症患者の血中BDNF）.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/10/01 | Date seet (BDNF in CO paietns).xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/60983
