UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021732 |
|---|---|
| Receipt number | 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 | 2025/04/07 15:06:23 |
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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
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
kakui-s@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025067
