UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042153 |
|---|---|
| Receipt number | R000048117 |
| Scientific Title | A study to establish a prognosis prediction method for cochlear implants using resting fMRI and structural MRI auditory central target analysis |
| Date of disclosure of the study information | 2020/10/18 |
| Last modified on | 2025/02/18 10:17:25 |
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Basic information
Public title
A study to establish a prognosis prediction method for cochlear implants using resting fMRI and structural MRI auditory central target analysis
Acronym
A study to establish a prognosis prediction method for cochlear implants using resting fMRI and structural MRI auditory central target analysis
Scientific Title
A study to establish a prognosis prediction method for cochlear implants using resting fMRI and structural MRI auditory central target analysis
Scientific Title:Acronym
A study to establish a prognosis prediction method for cochlear implants using resting fMRI and structural MRI auditory central target analysis
Region
| Japan |
Condition
Condition
Hard of hearing
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of wearing a hearing aid or cochlear implant is estimated from the results of structural MRI of the auditory center target analysis of candidate patients with hearing aids or cochlear implants.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective prognosis of hearing aids or cochlear implants by MRI auditory center target analysis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients over 7 years old
(2) Average hearing level of 70 dBHL or higher on both sides by quadrant method
(3) Patients who are scheduled to wear hearing aids or have cochlear implant surgery
(4) Patients who can understand the content of the study and have obtained the written consent of the patient or his / her substitute.
Key exclusion criteria
(1) Patients who have artificial objects in their bodies that do not support MRI and are contraindicated for MRI imaging
(2) Women who are pregnant or may become pregnant
(3) Patients with gross lesions in the skull
(4) Patients with strong intracranial artifacts on MRI
(5) When the principal investigator and the research coordinator judge that participation in this research is not appropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shujiro |
| Middle name | |
| Last name | Minami |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Otolaryngology
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguroku Tokyo Japan
TEL
03-3411-0111
shujirominami@me.com
Public contact
Name of contact person
| 1st name | Shujiro |
| Middle name | |
| Last name | Minami |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Otolaryngology
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguroku Tokyo Japan
TEL
03-3411-0111
Homepage URL
shujirominami@me.com
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
Clinical Research Central Ethics Review Board
Address
2-5-21 Higashigaoka Meguroku Tokyo
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
| 2020 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38082456/
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 12 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study (prospective cohort study)
Management information
Registered date
| 2020 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048117
