UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008792 |
|---|---|
| Receipt number | R000010283 |
| Scientific Title | Investigation of auditory plasticity in tinnitus patients by using transcranial direct current stimulation during functional MRI |
| Date of disclosure of the study information | 2012/08/31 |
| Last modified on | 2015/08/28 15:17:58 |
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Basic information
Public title
Investigation of auditory plasticity in tinnitus patients by using transcranial direct current stimulation during functional MRI
Acronym
Auditory plasticity in tinnitus by using tDCS during fMRI
Scientific Title
Investigation of auditory plasticity in tinnitus patients by using transcranial direct current stimulation during functional MRI
Scientific Title:Acronym
Auditory plasticity in tinnitus by using tDCS during fMRI
Region
| Japan |
Condition
Condition
tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal auditory plasticity in tinnitus patients by using transcranial direct current stimulation during functional MRI
Basic objectives2
Others
Basic objectives -Others
Clarification of clinical state
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Data obtained by fMRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
tinnitus patients treated with transcranial direct current stimulation
Interventions/Control_2
controls (without tinnitus)
Interventions/Control_3
controls (without tinnitus) over tDCS
Interventions/Control_4
tinnitus patients without tDCS
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic tinnitus patients with a history of over 3 months
Key exclusion criteria
fluctuating hearing loss
tinnitus with a history of less than 3 months
patients who cannot be tested by MRI
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0353633827
oishin@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 1608582
TEL
0353633827
Homepage URL
oishin@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 31 | 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
| 2012 | Year | 08 | Month | 28 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010283
