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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008095
Receipt No. 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 2013/04/01

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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
Email

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
Email morie@med.tohoku.ac.jp

Sponsor
Institute IMZ-TBI Executive Committee
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 04 Day
Last modified on
2013 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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