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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016807
Receipt No. R000019495
Scientific Title Pathophysiology clarification of spasmodic dysphonia by functional MRI
Date of disclosure of the study information 2015/06/01
Last modified on 2018/01/06

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Basic information
Public title Pathophysiology clarification of spasmodic dysphonia by functional MRI
Acronym Analysis of spasmodic dysphonia by fMRI
Scientific Title Pathophysiology clarification of spasmodic dysphonia by functional MRI
Scientific Title:Acronym Analysis of spasmodic dysphonia by fMRI
Region
Japan

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

Objectives
Narrative objectives1 To clarify pathophysiology of spasmodic dysphonia by fMRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Bold signal recorded by fMRI
Key secondary outcomes Voice Handicap Index



Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
65 years-old >
Gender Male and Female
Key inclusion criteria Patients of spasmodic dysphonia or muscle tension dystonia
VHI-10>=20
Key exclusion criteria Patients of dysphasia, organic disease of vocal code
History of botulinum toxin treatment less than 6 months before participation
Patients of mental disease
Patients of abuse of alchocol or medication
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Tateya
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 4 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL 075-751-3346
Email sdimaging@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Tateya
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL 075-751-3346
Homepage URL
Email sdimaging@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 06 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information he relationship of Bold signal between before and after type 2 thyroplasty

Management information
Registered date
2015 Year 03 Month 16 Day
Last modified on
2018 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019495

Research Plan
Registered date File name
2018/05/25 20180324SD研究実施計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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