UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048753 |
|---|---|
| Receipt number | R000055541 |
| Scientific Title | Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2022/08/25 11:37:41 |
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Basic information
Public title
Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Acronym
Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Scientific Title
Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Scientific Title:Acronym
Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively analyzed PET/CT images taken before and after treatment, which is presumed to change brain metabolism in clinical symptoms, and investigated the effects of each treatment on brain metabolism for the purpose of confirming brain metabolic changes.
Basic objectives2
Others
Basic objectives -Others
We facilitate the planning of rehabilitation programs and the development of assistive devices for brain injury patients in future.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Standardized uptake value (SUV), Lesion-to-normal uptake ratio (L/N)
Key secondary outcomes
Clinical evaluation, ABR/VEP/EEG, CT/MRI, blood analysis data, information of drug and surgical treatments
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) Patients who have been hospitalized at the Rehabilitation Center for Traumatic Apallics Chiba.
(2) Patients whose general condition is stable and who can be safely examined.
(3) Patients who have given written informed consent voluntarily from the patient himself/herself or from the legal representative of the patient who lacks the ability to consent after receiving a sufficient explanation for participating in this study.
Key exclusion criteria
(1) Patients whose general condition is unstable and cannot be safely examined.
(2) Patients who could not obtain written consent.
(3) Patients judged by the research investigator to be inappropriate for this study.
Target sample size
250
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
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, chiba-shi, Chiba, Japan
TEL
043-277-0061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Seki |
Organization
Rehabilitation Center for Traumatic Apallics Chiba
Division name
Medical accounting section
Zip code
261-0012
Address
3-30-1 Isobe, Mihama-ku, chiba-shi, Chiba, Japan
TEL
043-277-0061
Homepage URL
takahito-seki@chiba-ryougo.jp
Sponsor or person
Institute
Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Center for Traumatic Apallics Chiba
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, 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
自動車事故対策機構 千葉療護センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational analysis
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055541
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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