UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016807 |
|---|---|
| Receipt number | R000019495 |
| Scientific Title | Pathophysiology clarification of spasmodic dysphonia by functional MRI |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2021/09/19 10:30:56 |
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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 | Ichiro |
| Middle name | |
| Last name | Tateya |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
6068507
Address
4 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3346
sdimaging@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Tateya |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3346
Homepage URL
sdimaging@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
Kyoto University Hospital
Address
54 Shogoinkawaharamachi, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
https://www.nature.com/articles/s41598-020-73450-0
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-73450-0
Number of participants that the trial has enrolled
22
Results
We found overactivation in the left sensorimotor cortex and the left thalamus in SD patients, suggesting that voice perception activates different neural systems between SD patients and healthy participants. For SD patients, moreover, the magnitude of sensorimotor activation showed a significant positive correlation with symptom severity measured by voice handicap index-10, suggesting that signals from the sensorimotor cortex can be a new biomarker for assessing disease severity.
Results date posted
| 2021 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven patients with the adductor-type SD and 11 age- and gender-matched healthy participants underwent functional MRI.
Participant flow
Participants underwent functional MRI during a two-alternative
judgment task for auditory stimuli, which could be modal or falsetto voice.
Adverse events
none
Outcome measures
we submitted the three contrast images per participant to a analysis of variance (ANOVA) to examine the efects of stimulus type (modal voice, falsetto voice) and group (SD and control)
on brain activation.
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
| 2015 | Year | 04 | Month | 23 | Day |
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
| 2021 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.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 |
