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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025664
Receipt No. 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

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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
Email 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
Email skan@keio.jp

Sponsor
Institute Department of Otolaryngology, Keio Univesity
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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