UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025664 |
|---|---|
| Receipt number | R000029523 |
| Scientific Title | Study on the mechanism of therapeutic effect on tinnitus using fMRI |
| Date of disclosure of the study information | 2017/01/13 |
| Last modified on | 2017/01/13 16:47:16 |
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Basic information
Public title
Study on the mechanism of therapeutic effect on tinnitus using fMRI
Acronym
Study on tinnitus treatment effect by fMRI
Scientific Title
Study on the mechanism of therapeutic effect on tinnitus using fMRI
Scientific Title:Acronym
Study on tinnitus treatment effect by fMRI
Region
| Japan |
Condition
Condition
tinnitus
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze therapeutic effect of tinnitus using functional MRI.
Basic objectives2
Others
Basic objectives -Others
we explore the mechanism and compare fMRI data between the patients with and witout tinnitus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
we find out how the patinets with tinnitus improve.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We asked patinets to wear hering aid for tinnitus patients and patients without tinnitus (both have hearing loss).
Interventions/Control_2
We examine hearing tests, tinnitus tests
and fMRI analysis before and after hearing aid treatment for tinnitus patients and patients without tinnitus (both have
hearing loss) and the treatment mechanism of sound therapy wearing hearing aids.
Functional MRI photographs at the University of Tokyo Advanced Technology Center
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who can understand the contents of the research and obtain written informed consent
There are geriatric hearing loss (there are high-frequency hearing loss on both sides), and further classified into two groups with or without senile tinnitus.
Key exclusion criteria
If one of the following applies, it is excluded.
1 Patient without physical fitness to withstand the field test in the planned research period
2 Other patients who have severe complications, mental / psychological conditions, etc. and are considered inappropriate for participation in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
School of Medicine, Keio Univesity
Division name
Department of Otolaryngology
Zip code
Address
35 Shinjuku Shinanomachi Tokyo Japan
TEL
0353633827
skan@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
School of Medicine, Keio Univesity
Division name
Department of Otolaryngology
Zip code
Address
35 Shinjuku Shinanomachi Tokyo Japan
TEL
0353633827
Homepage URL
skan@keio.jp
Sponsor or person
Institute
Department of Otolaryngology, Keio Univesity
Institute
Department
Personal name
Funding Source
Organization
Tateishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Advanced Science and Technology The University of Tokyo,
Tokyo Medical Center
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
| 2017 | Year | 01 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | 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
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
