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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040497
Receipt No. R000046220
Scientific Title Neural mechanisms of psychological functions and speech in people who stutter: An MRI study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/22

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Basic information
Public title Neural mechanisms of psychological functions and speech in people who stutter: An MRI study
Acronym A study on neural mechanism of stuttering
Scientific Title Neural mechanisms of psychological functions and speech in people who stutter: An MRI study
Scientific Title:Acronym A study on neural mechanism of stuttering
Region
Japan

Condition
Condition Stuttering
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the effect of psychotherapy (self-compassion) on people who stutter and fluent controls using fMRI, questionnaires, interviews, etc. Investigate the structure of brain and metabolites of people who stutter and fluent controls using structural images (T1, DTI) and MRS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate brain activity, structual and functional connectivity, as well as the structure of brain and metabolites, using MRI before and after the intervention.
Key secondary outcomes Conduct questionnaires and interviews regarding stuttering severety, psychological functions, and cognitive fucntions etc. before and after the intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participants practice self-compassion approximately 15-30 minutes a day, five days a week over 4-8 weeks.
Interventions/Control_2 Participants do not practice self-compassion.
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Adolescents and adults who stutter and fluent controls. Participants are recruited from local self-help communities for people who stutter, or through website.
Key exclusion criteria Persons having speech, communication or hearing disorders except for stutteirng.
Persons currently receiving stuttering or psychiatric treatment.
Persons with contraindication for MRI.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Yokosawa
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address Kita 12, Nishi 5 Kita-ku, Sapporo, Hokkaido
TEL 011-716-2111
Email yokosawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Toyomura
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code 371-8514
Address 3-39-22 Showa-machi, Maebashi, Gunma
TEL 027-220-7111
Homepage URL
Email ak.toyomura@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Gunma University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Health Sciences, Hokkaido University
Address Kita 12, Nishi 5 Kita-ku, Sapporo, Hokkaido
Tel 011-716-2111
Email shomu@hs.hokudai.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
2020 Year 07 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2023 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 22 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046220

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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