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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041612
Receipt No. R000047501
Scientific Title fect effect of (TDCS) brain on anxiety and stuttering in adolescents
Date of disclosure of the study information 2020/09/11
Last modified on 2020/08/31

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Basic information
Public title The effect of direct electrical stimulation of (TDCS) brain on anxiety and stuttering in adolescents aged 15 to 18 years
Acronym anxiety and stuttering
Scientific Title fect effect of (TDCS) brain on anxiety and stuttering in adolescents
Scientific Title:Acronym TDCS
Region
Asia(except Japan)

Condition
Condition in adolescents 15 to 18 years of stuttering
Classification by specialty
Neurology Pediatrics Psychiatry
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of TDCS on anxiety and stuttering in adolescents
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes TDCS treatment is effective in reducinganxiety and stuttering
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 5
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Pre-test adolescents with stuttering will first be taken.
Interventions/Control_2 The stuttering adolescents in the study were divided into control and experimental groups.
Interventions/Control_3 The intervention is performed on the experimental group and the control group does not receive any treatment.
Interventions/Control_4 The intervention protocol utilizes acceptance and commitment-based treatment based on the Strosahl, Hayse, and Wilson treatment guidelines
Interventions/Control_5 Running time will be eight hour and a half sessions in group, once a week.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Stutter's diagnosis by speech therapist,Age 15 to 18 years, Parental consent of adolescents, and Adolescent consent to participate in the study, no co-treatment with intervention
Key exclusion criteria Lack of regular attendance at treatment sessions, no homework, no pre-test and post-test questionnaires.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name mahsa &amp;Mohsen
Middle name
Last name Taherifard &amp; saeidmanesh
Organization University of Science and Art
Division name resarcher & Assistant Professor
Zip code 8916713335
Address University of Science and Art, Daneshjoo Boulevard, Yazd
TEL 00989139757808
Email mitra.752001@yahoo.com

Public contact
Name of contact person
1st name mahsa &amp; Mahdiyeh
Middle name
Last name Taherifard &amp; Azizi
Organization Department of Psychology
Division name Faculty of Humanities
Zip code 8357139098
Address University of Science and Art, Daneshjoo Boulevard, Yazd
TEL 00989139757808
Homepage URL
Email mitra.752001@yahoo.com

Sponsor
Institute University of Science and Art
Institute
Department

Funding Source
Organization personal
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Iran

Other related organizations
Co-sponsor mahsa Taherifard
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Science and Art
Address University of Science and Art, Daneshjoo Boulevard, Yazd
Tel 00983538264080
Email mitra.752001@yahoo.com

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 09 Month 11 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 09 Month 05 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 13 Day
Last follow-up date
2021 Year 01 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 08 Month 31 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047501

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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