UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011111 |
|---|---|
| Receipt number | R000013014 |
| Scientific Title | Spinal blood flow and metabolism in neurological diseases |
| Date of disclosure of the study information | 2013/07/15 |
| Last modified on | 2014/02/10 19:19:53 |
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Basic information
Public title
Spinal blood flow and metabolism in neurological diseases
Acronym
Spinal blood flow and metabolism in neurological diseases
Scientific Title
Spinal blood flow and metabolism in neurological diseases
Scientific Title:Acronym
Spinal blood flow and metabolism in neurological diseases
Region
| Japan |
Condition
Condition
motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of spinal blood flow, metabolism, and neuronal loss in neurological diseases.
Basic objectives2
Others
Basic objectives -Others
Understanding pathophysiological mechanism of each neurological disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Signal intensity of each PET image (11C- flumazenil,18F- FDG, 15O-H2O) (spinal cord C1-C6 level)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET scan study with 11C-flumazenil
Interventions/Control_2
PET scan study with 18F- FDG
Interventions/Control_3
PET scan study with 15O-H2O
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatient or ambulatory patient of Department of Neurology, Okayama University Hospital.
And these patienets are diagnosised as motor neuron disease incluiding ALS, multiple sclerosis, stroke, parkinson disease, spinocerebellar ataxia, and multiple system atrophy
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Abe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Neurology
Zip code
Address
2-5-1 Shikatacho, Okayama
TEL
81-86-235-7365
tooy@d1.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Yamashita |
Organization
Okayama University Hospital
Division name
Neurology
Zip code
Address
2-5-1 Shikatacho, Okayama
TEL
086-235-7365
Homepage URL
toruyamashita@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 07 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 16 | 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
| 2013 | Year | 07 | Month | 03 | Day |
Last modified on
| 2014 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013014
