Effectiveness of Trans-Cranial Direct Current Stimulation (TDCS) on Neuropsychological Indices Associated with Social Skills, Theory of Mind, and Emotion Regulation in Children with Autism
This article deals with the effectiveness of Trans-Cranial Direct Current Stimulation (TDCS) on neuropsychological indices associated with social skills, Theory of Mind, and emotion regulation in children with autism.
Design
A randomized, single-blinded, sham controlled clinical trial with a parallel group
Settings and conduct
Setting: At Kanian Center in Sanandaj City;
Conduct: Receive Electrical Current in 10 Sessions for two Consecutive weeks
Blinding: Patients and Families were Unaware of which Group they were in
Participants/Inclusion and exclusion criteria
Participants: Children with Autism Diagnosis according to GARZ test;
Inclusion criteria: Being more than 6 years old; Families' satisfaction;
Exclusion criterion: History of Seizures
Intervention groups
The treatment protocol:
For the main Group, 10 Sessions of 15-minutes duration, with 1.5 mA electrical stimulation (the anodic or excitatory electrode on left DLFFC point and the cathode electrode on right DLFFC point);
For the Control Group, The device is connected, but no flow is received.
Main outcome variables
Electrical stimulation by TDCS enhances social skills, Theory of Mind and emotion regulation in autistic children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191025045234N1
Registration date:2020-01-31, 1398/11/11
Registration timing:retrospective
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
Omid Hoseinpanahi
Name of organization / entity
Kurdestan university
Country
Iran (Islamic Republic of)
Phone
+98 87 3316 6494
Email address
www.omidhoseinpanahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-08, 1398/04/17
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-07-08, 1398/04/17
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-10-09, 1398/07/17
Scientific title
Effectiveness of Trans-Cranial Direct Current Stimulation (TDCS) on Neuropsychological Indices Associated with Social Skills, Theory of Mind, and Emotion Regulation in Children with Autism
Public title
Effectiveness of Trans-Cranial Direct Current Stimulation (TDCS) in children with autism
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with autism according to Garz test
Diagnosed with autism according to Autism - Spectrum Quotient
Exclusion criteria:
No history of Seizures
Age
From 5 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
40
Children with Autism Spectrum Disorder
Actual sample size reached:
32
More than 1 sample in each individual
Actual sample size in each individual:
32
Children with Autism Spectrum Disorder
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Only patients receiving the intervention were kept blind, in order to determine the true impact of treatment
Placebo
Used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.UOK.REC.1389.027
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Social skills in autistic children
Timepoint
Before intervention and after intervention and one month after intervention
Method of measurement
Garz test, AQ Autism Assessment Test, Gersham & Elliott Social Skills Test, social skills checklist, Mind Theory Test, emotion regulation checklist
Secondary outcomes
1
Description
Improved Garz and AQ scores
Timepoint
Before intervention, after intervention and one month after intervention
Method of measurement
Garz Test, AQ Autism Assessment Test, Gersham & Eliot Social Skills Test, social skills checklist, Mind Theory Test, emotion regulation checklist, executive functions checklist
Intervention groups
1
Description
Intervention Group: The treatment protocol consists of ten 15-minute sessions of 1.5 mA electrical stimulation (anodic or excitation electrodes on Left DLFFC point and cathode electrode on right DLFFC point).
Category
Treatment - Devices
2
Description
Control Group: The device was connected to the patient without transmitting electricity.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Children 's Rehabilitation Center of Kanian Sanandaj Autism
Full name of responsible person
Shahrzad Ghaderi
Street address
Keshavarz Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6619656811
Phone
+98 87 3323 8818
Fax
+98 87 3323 8818
Email
shahrzad.ghaderi90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Hoseinpanahi
Street address
Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Fax
+98 87 3366 4600
Email
www.omidhoseinpanahi@gmail.com
Grant name
NO
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Kurdistan
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
University of Kurdistan
Full name of responsible person
Omid Hoseinpanahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Enghelab St.
City
Sanandaj
Province
Kurdistan
Postal code
6615645585
Phone
+98 87 3315 6857
Fax
+98 87 3315 6857
Email
www.omidhoseinpanahi@gmail.com
Web page address
https://www.uok.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Hosseinpanahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Enghelab St.
City
Sanandaj
Province
Kurdistan
Postal code
6615645585
Phone
+98 87 3315 6857
Fax
+98 87 3315 6857
Email
www.omidhoseinpanahi@gmail.com
Web page address
https://www.uok.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Hoseinpanahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Fax
+98 87 3366 4600
Email
www.omidhoseinpanahi@gmail.com
Web page address
https://www.uok.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The Results of the Experimental and Control Groups will be Published after Comparison and Statistical Processing
When the data will become available and for how long
After Completing the Statistic Tasks
To whom data/document is available
Researchers Working in Academic and Scientific Institutions
Under which criteria data/document could be used
Use in other Research is Permitted by Reference
From where data/document is obtainable
Refer to the Email of a Researcher Named Omid Hossein Panahi
What processes are involved for a request to access data/document
After Sending the Email the Information will be Sent After one Month