Comparing the effect of transcranial direct current stimulation (tDCS) with and without cognitive rehabilitation based on computerized task and occupational performance on executive functions in children with autism spectrum disorder aged 8-14 years
The aim of this study is to compare the effect of transcranial direct current stimulation (tDCS) with and without cognitive rehabilitation based on computer tasks and occupational performance on executive function skills of children with autism spectrum disorder (ASD) aged 8-14 years in terms of behavioral characteristics and performance.
Design
This study is a clinical trial with a control group and single-blind with a follow-up phase. Participants will convenience sampling in four groups: tDCS, tDCS with computer-based cognitive rehabilitation, tDCs with occupation-based cognitive rehabilitation, and control group receiving routine cognitive training therapy. They will be evaluated before and after the mentioned interventions and will be followed up one month later.
Settings and conduct
The rehabilitation clinics of Tehran
Participants/Inclusion and exclusion criteria
diagnosis of ASD level 1
age 8-14 years
not receiving tDCS since last year
not receiving drug since two weeks ago
Intervention groups
In this study, there are 4 groups: one group receives only tDCS, the second group receives tDCS with cognitive rehabilitation in the form of computer tasks, the third group receives tDCS with cognitive rehabilitation focused on occupational performance, and the fourth group as control, receives common cognitive educational interventions.
Main outcome variables
The outcomes of the present study are executive functions in terms of behavioral characteristics and performance.
General information
Reason for update
Acronym
transcranial direct current stimulation (tDCS); autism spectrum disorder (ASD)
IRCT registration information
IRCT registration number:IRCT20150223021208N2
Registration date:2020-11-20, 1399/08/30
Registration timing:prospective
Last update:2020-11-20, 1399/08/30
Update count:0
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
Samauneh Karamali Esmaeili
Name of organization / entity
Iran Univercity of Medical Sciences- School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 6025
Email address
samauneh.esmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of transcranial direct current stimulation (tDCS) with and without cognitive rehabilitation based on computerized task and occupational performance on executive functions in children with autism spectrum disorder aged 8-14 years
Public title
Comparing the effect of transcranial direct current stimulation (tDCS) with cognitive rehabilitation in autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 8-14 years with a diagnosis of level 1 autism spectrum disorder based on the diagnosis of a child psychiatrist and assessment by the GARS
If receive medication, at least two weeks have been passed since the start of the drug
Exclusion criteria:
comorbid neurological disorder
receiving the tDCS during the previous year
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a comparison of 4 groups is considered that the participants in each group are not aware of the other groups and the place of the treatment they receive in the study (is it intervention or control?!).
The therapists who provide interventions are not aware of the main purpose of the study and the existence of four groups with different interventions.
Data analysis is performed by a person who has no contact with the participants, assessors and therapists
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.141
Health conditions studied
1
Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
executive function
Timepoint
before, after, and 1 month after the intervention (follow-up)
Method of measurement
Behavior Rating Inventory of Executive Function (BRIEF)- Wisconsin Card Sorting Test (WCST)- Tower of London (ToL)- Stroop test
2
Description
occupational performance
Timepoint
before, after, and 1 month after the intervention (follow-up)
Method of measurement
Canadian Occupational Performance Measure (COPM)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: twelve sessions of tDCS with electrode size 25 CM2 and 1 mA intensity in the left dorsolateral prefrontal cortex region (F3), which is determined according to the international classification system 10-20, for 20 minutes every week for 3 weeks (Four sessions per week) will provide; the reference electrode is placed on F4. Thirty seconds after starting current stimulation gradually reaches 1 mA and the final 30 seconds of current stimulation gradually decreases from 1 mA to zero.
Category
Treatment - Devices
2
Description
Intervention group 2: tDCS with computerized cognitive rehabilitation- tDCS is described in the first intervention. When receiving tDCS, the child will simultaneously perform computerized tasks for 12 sessions of 20 minutes. These tasks are in the form of computerized games to strengthen working memory, attention and concentration, problem solving, planning, inhibition and other executive function skills.
Category
Rehabilitation
3
Description
Intervention group 3: tDCS with occupation-based cognitive rehabilitation- tDCS is described in the first intervention. occupational cognitive rehabilitation in this study included 12 sessions of cognitive rehabilitation, two sessions per week, each session lasting 60 minutes; The first 30 minutes of each occupational cognitive rehabilitation program session will include meaningful and purposeful activities and games to improve executive functions, and the second 30 minutes of these sessions will focus on teaching the occupations that each child's parents determine in interviewing the Canadian Occupational Performance Measure (COPM) and prioritize the child's problems in doing daily activities by stating their perceptions about child's performance and their satisfaction.
Category
Rehabilitation
4
Description
Control group: traditional cognitive training interventions- intervention through training strengthens the executive function components such as working memory, attention and concentration, problem solving, planning, and inhibition using educational equipment and pen and paper tasks. Children in this group will receive 12 training sessions for 6 weeks (two sessions per week), 1 hour per session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Autism charity Association
Full name of responsible person
Dr saeedeh saleh-ghaffari
Street address
No. 8, East Laleh Boulevard, After Hemmat Bridge, South Sattari highway, Tehran
Iran University of Medical Sciences Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Dr Samaneh Karamali Esmaili
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Department of Occupational therapy, School of Rehabilitation, Madadkaran alley, Shah-Nazari Street, Mirdamad Boulevard, Tehran,
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
samauneh.esmaeili@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehdi Alizadeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Occupational Therapy, School of Rehabilitation, Madadkaran Alley, Shah-Nazari Street, Mirdamad Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
mehdii.alizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Samaneh Karamali Esmaili
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Department of Occupational Therapy, School of Rehabilitation, Madadkaran Alley, Shah-Nazari Street, Mirdamad Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
samauneh.esmaeili@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Informed consent form: the word file can be made available.
Clinical study report: will be published in several articles.
When the data will become available and for how long
Informed consent form: After publishing the last paper
Clinical study report: After publication (if the article would not be free, if people email us a request and state the purpose of using the article, we will provide the full-text of article.)
To whom data/document is available
Informed consent form: Academic researchers
Clinical study report: everyone who is interested to the topic.
Under which criteria data/document could be used
Informed consent form: The users should announce the purpose of using the informed consent form.
Clinical study report: for clinical and research uses
From where data/document is obtainable
Informed consent form: Send us an e-mail
Clinical study report: Search databases or send us an email.
What processes are involved for a request to access data/document
Informed consent form: After sending the email and announcing the purpose of using the consent form or the clinical study report, it will be sent to them within a week.