UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054947 |
|---|---|
| Receipt number | R000062776 |
| Scientific Title | Development of a kinship 3D visualization program for rehabilitation of patients with disorder of consciousness |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2024/07/12 13:31:01 |
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Basic information
Public title
Development of a kinship 3D visualization program for rehabilitation of patients with disorder of consciousness
Acronym
Kinship 3D rehabilitation for DoC
Scientific Title
Development of a kinship 3D visualization program for rehabilitation of patients with disorder of consciousness
Scientific Title:Acronym
Kinship 3D rehabilitation for DoC
Region
| Japan |
Condition
Condition
Brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify brain areas in patients with disorder of consciousness where the perception of a close relative activates brain function using a mixed reality device with fMRI
Basic objectives2
Others
Basic objectives -Others
To develop an effective rehabilitation program based on changes in brain metabolism in the same areas
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Activation of specific brain regions by fMRI
Key secondary outcomes
Clinical evaluation of executive function, attention, memory, working memory, spatial cognition, disorientation, eye opening time, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
fMRI, Mixed Reality device
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with a diagnosis of moderate to severe disorder of consciousness with a score of 13 or less on the Glasgow Coma scale (GCS) at the onset of the accident
2) Patients whose general condition is stable and who can be safely examined and treated
3) Patients who are between 16 and 80 years of age at the time of consent
4) Patients who have been fully informed of their participation in this study and who have given free written informed consent, either by the patient himself/herself or legal representative
Key exclusion criteria
1) Patients who are unable to remain at rest
2) Patients who cannot safely undergo MRI due to metal in their bodies
3) Patients with neurological or psychiatric diseases or a history of such diseases
4) Patients who are judged by the principal investigator to be inappropriate for the examination
Target sample size
30
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
TEL
0432770061
t-yamaki@chiba-ryougo.jp
Public contact
Name of contact person
| 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
TEL
0432770061
Homepage URL
t-yamaki@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
Tel
0432770061
y-oomura@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
| 2024 | Year | 07 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062776
