UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021595 |
|---|---|
| Receipt number | R000024905 |
| Scientific Title | Clinical application of real-time functional MRI neuro-feedback for rehabilitation. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/06/08 16:16:21 |
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Basic information
Public title
Clinical application of real-time functional MRI neuro-feedback for rehabilitation.
Acronym
Clinical application of rtfMRI-NF for rehabilitation.
Scientific Title
Clinical application of real-time functional MRI neuro-feedback for rehabilitation.
Scientific Title:Acronym
Clinical application of rtfMRI-NF for rehabilitation.
Region
| Japan |
Condition
Condition
higher brain dysfunction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify feasibility of rtfMRI-NF as a clinical therapeutic application for the patients with higher brain dysfunction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
increase or decrease of BOLD signal with neuro-feedback while performing the focused attention task
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
to assess the efficacy neuro-feedback on BOLD change
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with mild higher brain dysfunction
healthy control
Key exclusion criteria
person who has contraindication to MRI, such as claustrophobia, pregnancy, tattoo, inplanted electrical devices (e.g. cardiac pacemaker)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomokazu Takakura |
Organization
Japan Organization of Occupational Health and Safety, Tokyo Rosai Hospital
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
4-13-21, Ohmori-Minami, Ohta-ku, Tokyo
TEL
03-3742-7301
t-takakura@tokyoh.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Takakura |
Organization
Japan Organization of Occupational Health and Safety, Tokyo Rosai Hospital
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
4-13-21, Ohmori-Minami, Ohta-ku, Tokyo
TEL
03-3742-7301
Homepage URL
t-takakura@tokyoh.rofuku.go.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety, Tokyo Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
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
東京労災病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024905
