UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008095 |
|---|---|
| Receipt number | R000009528 |
| Scientific Title | Study of 123I-Iomazenil SPECT for neurobehavioral deficits after traumatic brain injury |
| Date of disclosure of the study information | 2012/06/04 |
| Last modified on | 2024/01/14 13:39:37 |
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Basic information
Public title
Study of 123I-Iomazenil SPECT for neurobehavioral deficits after traumatic brain injury
Acronym
IMZ-TBI
Scientific Title
Study of 123I-Iomazenil SPECT for neurobehavioral deficits after traumatic brain injury
Scientific Title:Acronym
IMZ-TBI
Region
| Japan |
Condition
Condition
neurobehavioral deficits after traumatic brain injury
Classification by specialty
| Neurology | Radiology | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the abilities of 123I-iomazenil SPECT to detect the diffuse axonal injury and to correlate neurobehavioral deficits in patients with traumatic brain injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Detectability of diffuse axonal injury with 123I-Iomazenil SPECT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Injection of Benzodine (123I-Iomazenil) and acquisition of SPECT
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
Patients with neurobehavioral deficits after traumatic brain injury, in whom diffuse axonal injury is the central feature accoding to history of the accident, symptom, and CT/MRI not accompanying severe contusion, hematoma, and other pathologies.
6-60 months after the brain injury.
Key exclusion criteria
Those who need to continue Benzodiazepines without interruption for 1 week.
Those who perform neuropsychological tests.
Those who have a history of mental or neurologiocal disorders before the brain injury.
Those in whom PTSD were strongly suspected.
Those with hypopituitarism.
Left-handed
Those who are in dispute or are very likely to dispute because of the brain injury.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Mori |
Organization
Tohoku university graduate school of medicine
Division name
Department of behavioral neurology and cognitive neuroscience
Zip code
Address
2-1,Seiryo-machi,Aoba-ku,Sendai 980-8575,Japan
TEL
022-717-7356
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuro Mori |
Organization
Tohoku university graduate school of medicine
Division name
Department of behavioral neurology and cognitive neuroscience
Zip code
Address
2-1,Seiryo-machi,Aoba-ku,Sendai 980-8575,Japan
TEL
022-717-7356
Homepage URL
morie@med.tohoku.ac.jp
Sponsor or person
Institute
IMZ-TBI Executive Committee
Institute
Department
Personal name
Funding Source
Organization
Foundation for Advancement of International Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 06 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 24 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009528
