UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019554 |
|---|---|
| Receipt number | R000022614 |
| Scientific Title | Global analysis of brain connectivity in patients with chronic spinal cord injury using resting functional MRI |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/11/03 14:26:58 |
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Basic information
Public title
Global analysis of brain connectivity in patients with chronic spinal cord injury using resting functional MRI
Acronym
Analysis of functional brain connectivity using
resting fMRI in chronic SCI patients
Scientific Title
Global analysis of brain connectivity in patients with chronic spinal cord injury using resting functional MRI
Scientific Title:Acronym
Analysis of functional brain connectivity using
resting fMRI in chronic SCI patients
Region
| Japan |
Condition
Condition
Chronic spinal cord injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the changes of brain connectivity in patients with chronic spinal cord injury using fMRI and to reveal the association of these changes
with functional recovery.
Basic objectives2
Others
Basic objectives -Others
Functional brain connectivity
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyze the brain connectivity in patients with chronic spinal cord injury using resting fMRI, and to analyze the change of brain connectivity after spinal cord injury.
Key secondary outcomes
We perform a neurologic evaluation with ASIA score.
We perform examination of neurologic symptom
with Nurick score.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To perform neurologic evaluation, neurological symptoms examination and taking resting fMRI.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients with informed consent
over the age of 20 years-old,
over 6 months after SCI,
who take treatment for spinal cord injury
at Keio University hospital.
Key exclusion criteria
･Poor general condition due to SCI
･Difficult to take fMRI
･No informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Orthopaedic Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
03-5363-3812
masa@a8.keio.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Orthopaedic Surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
03-5363-3812
Homepage URL
masa@a8.keio.jp
Sponsor or person
Institute
Keio University Scholl of medicine
Institute
Department
Personal name
Funding Source
Organization
The Uehara Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Keio University
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
慶応義塾大学医学部/慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022614
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
