UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015456 |
|---|---|
| Receipt number | R000017956 |
| Scientific Title | Higher brain dysfunction after traumatic brain injury: association with serotonin transporter deficiency. |
| Date of disclosure of the study information | 2014/11/30 |
| Last modified on | 2023/10/24 09:36:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Higher brain dysfunction after traumatic brain injury: association with serotonin transporter deficiency.
Acronym
Serotonin transporter after traumatic brain injury.
Scientific Title
Higher brain dysfunction after traumatic brain injury: association with serotonin transporter deficiency.
Scientific Title:Acronym
Serotonin transporter after traumatic brain injury.
Region
| Japan |
Condition
Condition
traumatic brain injury
Classification by specialty
| Radiology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate serotonin transporter function in patients with higher brain dysfunction after traumatic brain injury.
Basic objectives2
Others
Basic objectives -Others
Quantitative assessment of serotonin transporter function.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Functional association between higher brain function and serotonin transporter function.
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
Patients under cognitive rehabilitation for the treatment of chronic traumatic brain injury.
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
1. Age 20 years old.
2. Patients capable of a standard rehabilitation program.
3. Patients with written informed consent.
4. No contraindication for standard clinical imaging procedures (I-123 IMP SPECT, Brain MRI etc).
Key exclusion criteria
1. Age less than 20 years old
2. Age equal or greater than 60 years od
3. Patients incapable of standard imaging or neuropsychological testing.
4. Patients with under neuropsychological medication before rehabilitation.
5. Higher brain dysfunction due to non TBI
6. Woman with possible pregnancy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Hattori |
Organization
Hokkaido University
Division name
Dept. of Molecular Imaging
Zip code
Address
Hokkaido, Japan
TEL
011-706-5152
nhattori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Hattori |
Organization
Hokkaido University
Division name
Dept. of Molecular Imaging
Zip code
Address
Hokkaido, Japan
TEL
011-706-5152
Homepage URL
nhattori@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
| 2014 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2014 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017956
