UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001357 |
|---|---|
| Receipt number | 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 13:57:31 |
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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)
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
s-den@momo.so-net.ne.jp
Sponsor or person
Institute
Keio University, School of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001648
