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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021732
Receipt No. R000025067
Scientific Title A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma
Date of disclosure of the study information 2016/04/22
Last modified on 2016/06/20

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Basic information
Public title A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma
Acronym A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma
Scientific Title A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma
Scientific Title:Acronym A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma
Region
Japan

Condition
Condition Higher brain dysfunction following traumatic brain injury
Classification by specialty
Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examined chronological changes of IomazenilSPECT is checked in higher brain dysfunction by cerebral trauma, and determine what an abnormal findings site means, primary injury or the second injury, whether there is reversibility, and examine it prosepectively how it is associated with the change of the nerve psychological test and clinical manifestations prospectively, and how it is associated with findings of the MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes <Efficacy>
Presence or absence of changes of IMZ-SPECT one year later
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 Prevention
Type of intervention
Other
Interventions/Control_1 Diagnosis by Iomazenil 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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who present with higher brain dysfunction by cerebral trauma (TBI) who are are visiting a hospital for treatment or the hospitalized patient in a Hokkaido University Hospital Rehabilitation Medicine
(1) The Age is more than 15-year-old patient at the agreement acquisition. The sex does not matter.
(2) The patients without the contraindication for the MRI and SPECT as a preoperative routine imaging study
(3) The patients that a document agreement by the free will of the patients or legal representative was obtained after having received enough explanation and understanding in participation of this study
(4) The patients who are more than 2 months after injury
(5) The patients without the contraindication for the Standard therapies method including the rehabilitation
Key exclusion criteria (1) The patients who cannot discontinue benzodiazepine drugs for one week
(2) The patients who cannot conduct various tests such as nerve psychological tests
(3) The patients with a history of other mental disorder and neurologic disease
(4) The patient with serious liver dysfunction, serious renal dysfunction, or dysuria
(5) In addition, the patient whom a study person in charge judged to be inadequate as subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Shiga
Organization Hokkaido University, Graduate School of Medicine
Division name Department of Nuclear Medicine
Zip code
Address N15,W7,Kita-Ku, Sapporo
TEL 011-706-5152
Email tshiga@hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tohru Shiga
Organization Hokkaido University, Graduate School of Medicine
Division name Department of Nuclear Medicine
Zip code
Address N15,W7,Kita-Ku, Sapporo
TEL 011-706-5152
Homepage URL
Email kakui-s@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Self-procurement
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
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
2016 Year 04 Month 22 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
Date of protocol fixation
2015 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 22 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
2016 Year 04 Month 01 Day
Last modified on
2016 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025067

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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