UMIN-CTR Clinical Trial

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 &Mohsen Middle name Last name Taherifard & 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 & Mahdiyeh Middle name Last name Taherifard & 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