UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011643 |
|---|---|
| Receipt number | R000013615 |
| Scientific Title | repetitive Transcranial Direct Current Stimulation on tinnitus patients |
| Date of disclosure of the study information | 2013/09/03 |
| Last modified on | 2015/05/08 10:43:36 |
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Basic information
Public title
repetitive Transcranial Direct Current Stimulation on tinnitus patients
Acronym
repetitive tDCS on tinnitus
Scientific Title
repetitive Transcranial Direct Current Stimulation on tinnitus patients
Scientific Title:Acronym
repetitive tDCS on tinnitus
Region
| Japan |
Condition
Condition
tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate effects of tDCS on treating tinnitus in patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
THI-12
Key secondary outcomes
loudness, HADS, VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
tDCS weekly for 8 weeks
Interventions/Control_2
tDCS 10 days for 2 consecutive weeks
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
chronic tinnitus lasting for more than 3 months
Key exclusion criteria
fluctuating hearing loss
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Otolaryngology- head and neck surgery
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
03-5363-3827
oishi_naoki@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Otolaryngology- head and neck
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
03-5363-3827
Homepage URL
oishi_naoki@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | 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
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013615
