UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017175 |
|---|---|
| Receipt number | R000019929 |
| Scientific Title | Alteration of cortical circuit in the auditory pathway during and after hearing rehabilitation |
| Date of disclosure of the study information | 2015/04/28 |
| Last modified on | 2023/04/25 09:44:16 |
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Basic information
Public title
Alteration of cortical circuit in the auditory pathway during and after hearing rehabilitation
Acronym
Imaging of central auditory pathway
Scientific Title
Alteration of cortical circuit in the auditory pathway during and after hearing rehabilitation
Scientific Title:Acronym
Imaging of central auditory pathway
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish an imaging method quantifying changes in the central auditory pathway in response to the changes in hearing and hearing rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MR imaging of the brain during and after changes in hearing (including rehabilitation)
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
| Device,equipment |
Interventions/Control_1
MRI
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
Hearing loss patient who is going to be treated.
Key exclusion criteria
Contraindication cases to MR scan
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Oishi |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-5363-3827
oishina@keio.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Masato |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku, Tokyo
TEL
03-5363-3827
Homepage URL
mtfuji@keio.jp
Sponsor or person
Institute
Department of Otolaryngology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW, JSPS, AMED, Self funding
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 Keio Univesity
Address
35 Shinanomachi Shinjuku
Tel
03-3353-1211
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
10
Results
under analyses
Results date posted
| 2023 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not opened
Participant flow
not opened
Adverse events
not opened
Outcome measures
not opened
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hearing and vestibular test results, and imaging
Management information
Registered date
| 2015 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019929
