UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043004 |
|---|---|
| Receipt number | R000049098 |
| Scientific Title | Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury |
| Date of disclosure of the study information | 2021/01/14 |
| Last modified on | 2023/04/05 15:30:03 |
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Basic information
Public title
Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury
Acronym
Finger FDGPET for sTBI
Scientific Title
Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury
Scientific Title:Acronym
Finger FDGPET for sTBI
Region
| Japan |
Condition
Condition
Chronic severe traumatic brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury by 18F-FDGPET/CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUV and Video judgment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are hospitalized in our center
2. Subjects who took 18F-FDG PETCT between October 2019 and October 2020
2.Subjects who have provide informed consent by themselves or their family and adhere to the protocol
Key exclusion criteria
1.Subjects who have medical instability and cannot perform examinations safely
2.Subjects who cannot provide informed consent and adhere to the protocol
3.Subjects who are not performed 18F-FDG PETCT
4.Subjects who have difficulty bending and extending their fingers (Modified Ashworth Scale 4)
5. Subjects who have spinal cord injury in the past
6. Subjects with poor control of diabetes mellitus
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery & PET imaging division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
TEL
043-277-0061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Takemi |
| Middle name | |
| Last name | Murayama |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Neurosurgery & Rehabilitation division
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
TEL
043-277-0061
Homepage URL
t-murayama@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Address
3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
Tel
043-277-0061
takahito-seki@chiba-ryougo.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 | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/hbm.26270
Number of participants that the trial has enrolled
17
Results
To predict voluntary movement in severe TBI patients, the results of patients' video were compared with the SUV in the primary motor cortex by resting state FDGPET imaged 1 year prior. Results showed that SUV in the left and right proximal limb of the primary motor cortex may reflect contralateral voluntary movement. A mean cutoff SUV of 5.47 is useful for differentiating between voluntary and involuntary movements.
Results date posted
| 2023 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 16 | Day |
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 | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049098
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| Registered date | File name |
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