UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040497 |
|---|---|
| Receipt number | 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 | 2025/04/17 23:52:51 |
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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 4-12 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 stuttering.
Persons currently receiving 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
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
ak.toyomura@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | 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
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046220
