Protocol summary

Study aim
The effectiveness of tdcs: in recognizing different facial emotional states and autism symptoms
Design
Due to the non-random assignment of participants into two experimental and control groups, the present study was a quasi-experimental study with a pre-test-post-test design with a non-equivalent control group without follow-up. Descriptive statistics including mean and standard deviation for control and experimental groups in pre-test, post-test were calculated and reported. The effect of in-group and out-group factors on the recognition of different facial emotional states and autism symptoms was analyzed using simple mixed variance analysis.
Settings and conduct
The research was conducted in Adalat School in Briyank, and a speech was given about the purpose and method of its implementation with parents and teachers, and they also answered the autism treatment evaluation list completely. . Each photo was shown for 10 seconds and the children determined the type of excitement in the photo. 10 tdcs sessions were performed three times a week. The experimental group was treated with the anodal method for 15 minutes and the control group was treated with sham for 20 seconds. After the completion of the re-sessions, the participants were re-tested for the recognition of facial emotional states and the autism symptoms questionnaire.
Participants/Inclusion and exclusion criteria
Entry criteria: informed consent of parents and school officials, receiving a diagnosis of autism disorder by a specialist, age range 6 to 17
Intervention groups
Multiple variables of the research by separating control and experimental groups, pre-test, post-test
Main outcome variables
Efficacy of tDCS; left frontal lateral posterior region; signs of autism; recognition of different facial emotional states in both positive and negative emotions

General information

Reason for update
Acronym
etdcs
IRCT registration information
IRCT registration number: IRCT20161112030849N2
Registration date: 2024-04-17, 1403/01/29
Registration timing: retrospective

Last update: 2024-04-17, 1403/01/29
Update count: 0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Maasoome Mousavi
Name of organization / entity
Shahid Beheshti university , Faculty of Psychology and Educational Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 5352
Email address
ma_mousavi@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-18, 1397/12/27
Expected recruitment end date
2019-08-09, 1398/05/18
Actual recruitment start date
2019-08-19, 1398/05/28
Actual recruitment end date
2019-10-20, 1398/07/28
Trial completion date
2019-12-19, 1398/09/28
Scientific title
Effectiveness of Anodal Transcranial Direct Current Stimulation of Left Dorsolateral Prefrontal Cortex in Facial Emotion Recognition and Clinical Symptoms of Boys With Autism Spectrum Disorder
Public title
Effectiveness of Anodal Transcranial Direct Current Stimulation of Left Dorsolateral Prefrontal Cortex in Facial Emotion Recognition and Clinical Symptoms With Autism Spectrum Disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Entry requirements 1. Age range between 6 and 17 years Male gender Having an autism disorder in the middle spectrum
Exclusion criteria:
Not having the problem of epilepsy
Age
From 6 years old to 17 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Actual sample size reached: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization Randomization Unit: Individual Randomization Tool: Like a table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
A blinded single strain method was performed. All subjects and their parents in the control group were not aware that electrical stimulation was not performed, and the specialist who performed the data test was not aware of the grouping and treatment.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University
Street address
Tehran, Quds town (west), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
tehran
Province
Tehran
Postal code
1983969411​
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SBU.REC.1402.142

Health conditions studied

1

Description of health condition studied
Effectiveness of Anodal Transcranial Direct Current Stimulation of Left Dorsolateral Prefrontal Cortex in Facial Emotion Recognition and Clinical Symptoms of Boys With Autism Spectrum Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effectiveness of tdcs
Timepoint
At the beginning of the study and after 10 sessions
Method of measurement
Semistim Emotion Recognition Test and Autism Treatment Evaluation List

Secondary outcomes

1

Description
Autism symptoms
Timepoint
At the beginning of the study and after 10 sessions
Method of measurement
Half-stim Facial Emotional State Recognition Test and Autism Treatment Evaluation List

Intervention groups

1

Description
Selecting 11 people randomly in the control group and performing sham tdcs method on them
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
adalat School
Full name of responsible person
Mr. Taifeh
Street address
Tehran, Nawab highway, Briyank boulevard, next to Farhangian store
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 5573 5856
Email
gitinzi2017@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Tehran
Full name of responsible person
Ali Mazaheri
Street address
Shahid Shahriari Square, Evin, Tehran
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
gitinzi2017@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Tehran
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti university , Faculty of Psychology and Educational Sciences
Full name of responsible person
Maasoome Mousavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti university , Faculty of Psychology and Educational Sciences, number 317, Shahriari S
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2990 5352
Fax
Email
ma_mousavi@sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti university , Faculty of Psychology and Educational Sciences
Full name of responsible person
Maasoome Mousavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti university , Faculty of Psychology and Educational Sciences, number 317, Shahriari S
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2990 5352
Fax
Email
ma_mousavi@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti university , Faculty of Psychology and Educational Sciences
Full name of responsible person
Maasoome Mousavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti university , Faculty of Psychology and Educational Sciences, number 317, Shahriari S
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2990 5352
Fax
Email
ma_mousavi@sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
عدم رضایت شرکت کننده ها
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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