UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008792
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email oishin@keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Otolaryngology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.