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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001357
Receipt No. R000001648
Scientific Title Clinical effects of repetitive transcranial magnetic stimulation for treatment of tinnitus
Date of disclosure of the study information 2008/10/01
Last modified on 2015/03/04

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Basic information
Public title Clinical effects of repetitive transcranial magnetic stimulation for treatment of tinnitus
Acronym Clinical effects of repetitive transcranial magnetic stimulation for treatment of tinnitus
Scientific Title Clinical effects of repetitive transcranial magnetic stimulation for treatment of tinnitus
Scientific Title:Acronym Clinical effects of repetitive transcranial magnetic stimulation for treatment of tinnitus
Region
Japan

Condition
Condition tinnitus
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess clinical effect and safety of repetitive transcranial magnetic stimulation for treatment of tinnitus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Tinnitus loudness and masking level,
Questionnaires (VAS for tinnitus loudness and annoyance, Tinnitus Handicap Inventory)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1Hz, 90-120% motor threshold,
5 trains of 20 min (1200 pulse) on 5 working days
Interventions/Control_2 control positons, coil perpendicular to the skull
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Right-handed patients with chronic tinnitus (more than 6 months) enrolled in the study after giving written, informed consent
Key exclusion criteria metal in cranium, trauma or operation of brain, intracardiac lines, increased intracranial pressure, pregnancy, childhood, heart disease, cardiac pacemaker, medication pump, tricyclic anti-depressants, neuroleptics, febrile convulsion, epilepsy, family history of epilepsy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Inoue
Organization Keio University, School of medicine
Division name Department of otolaryngology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211(ext.62441)
Email s-den@momo.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Shinden
Organization Keio Univesity, School of medicine
Division name Department of otolaryngology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211(ext.62441)
Homepage URL
Email s-den@momo.so-net.ne.jp

Sponsor
Institute Keio University, School of medicine
Institute
Department

Funding Source
Organization None
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
2008 Year 10 Month 01 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 Completed
Date of protocol fixation
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 09 Month 04 Day
Last modified on
2015 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001648

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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