Protocol summary

Study aim
Effectiveness of tDCS on attention to eyes compared with other facial features in children with high-function autism by eye-tracker
Design
Two parallel group randomised trial with blinded postoperative care and outcome assessment,24 samples and changes is evaluated by a eye tracker(tobiiprox2-60hz)
Settings and conduct
The present study will be performed in Shohada -Tajrish Hospital for initial diagnosis and evaluation, the desired variables are evaluated by software (tobiiprox2-60hz) in the eye tracker by aware tester.It should be noted that both the evaluator and the patients are unaware of the research (double blind) .the tDCS will place the anode electrode on the left Dorso latral pre forntal and the cathode on the right shoulder for 5 sessions for 20 minutes receive a current of 2 mA. For the control group, the electrode is placed in the same way and turn on sham.
Participants/Inclusion and exclusion criteria
Mild disorder according to (ASSQ)score higher than 88 Age range 15 -7 years Having verbal intelligence above 80 No physical and neurological disease There is no metal implant in the body Absence of infection and inflammation inside the brain In case of seizures, it is excluded from the study
Intervention groups
The intervention includes patients with autism who will receive a tDCS intervention for 5 sessions for 20 minutes at the anode electrode on the left DLPF and the cathode on the right shoulder and a current of 2 mA. the control includes patients with autism who will receive a sham tDCS intervention for 5 sessions for 20 minutes at the anode electrode on the left DLPF and the cathode on the right shoulder
Main outcome variables
The total number of fixation eye and the duration of the fixation time done on the eye

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211116053071N1
Registration date: 2021-12-21, 1400/09/30
Registration timing: registered_while_recruiting

Last update: 2021-12-21, 1400/09/30
Update count: 0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
ashkan Irani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 4208
Email address
irani.ot@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transcranial direct current stimulation on attention to eyes compared with other facial features in children with autism spectrum by eye-tracker
Public title
effectiveness of tDCS on attention to eyes in children with autism spectrum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of high-functioning autism by a pediatric psychiatrist based on criteria DSM-V and confirmation of diagnosis using interview Kiddie-SADS Mild disorder according to the Autism spectrum Disorders Screening Questionnaire (ASSQ) Age range 15 -7 years Having normal or corrected visual acuity with glasses (with the approval of an optometrist) Lack of physical and neurological disease Discontinue the drug 72 hours before the intervention under the supervision of a physician Absence of metal implants in vivo
Exclusion criteria:
Suffering from neurological and neuropsychological diseases during the study At any stage of the study that the subject was not willing to continue to cooperate, can be excluded from the study
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization, each new person who enters the study uses the table of random numbers if the odd number is entered into the control group and if the even number is entered into the test group, and this is done until both groups are completed. continues . And except for the main researcher, persons will not know which group of study they have entered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are evaluated by a eye tracker, it should be noted that they are evaluated by a person familiar with the eye tracker and uninformed to research. but tDCS is placed on the skull in the same way in both the experimental group and the control group, but in the control group, tDCS is turned on as a sham, which is turned off after the device is turned on after the initial burning sensation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
vice-chancellor in Research Affair-Shhid Beheshti University of MedicalSciences
Street address
shariaty street , tajrish squarer, shohadai Tajrish hospital
City
tehran
Province
Tehran
Postal code
1989934148
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.500

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
1- Total number eye fixation done
Timepoint
The first session before interval and the after fifth session with an interval of five days
Method of measurement
by Eye Tracker

2

Description
Number of first fixation done
Timepoint
The first session before interval and the after fifth session with an interval of five days
Method of measurement
by Eye Tracker

3

Description
duration time of the first fixation
Timepoint
The first session before interval and the after fifth session with an interval of five days
Method of measurement
by Eye Tracker

4

Description
duration time of the first fixation to eye
Timepoint
The first session before interval and the after fifth session with an interval of five days
Method of measurement
by Eye Tracker

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system
Category
Rehabilitation

2

Description
Control group: Using direct electrical stimulation by a tDCS-aware tester for 5 sessions for 20 minutes and five sessions per week, the anode electrode will be placed on the left DLPF and the cathode on the right shoulder through pads impregnated with physiological serum (1% NaCl) And will receive a current of 2 mA. The electrodes are placed according to the 10-20 system but the device turns on like a sham and turns off after a minute
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadai Tajrish Hospital Department of Physical Medicine
Full name of responsible person
َAshkan Irani
Street address
Shariaty street,Tajrish squeer
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4209
Email
Ashkan2579@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
دکتر رایگانی
Street address
shariaty,tajrish
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4209
Email
Pr_shohada@sbmu.ac.ir
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 Medical Sciences
Proportion provided by this source
80
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 of Medical Sciences
Full name of responsible person
Ashkan Irani
Position
In charge of the neurosurgery department
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
shariaty, tajrish
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4209
Email
Ashkan2579@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
masood raigani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
shariaty, tajrish
City
tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2272 4209
Email
ashkan2579@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ashkan Irani
Position
In charge of the neurosurgery department
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
shariaty,tajrish
City
tehran
Province
Tehran
Postal code
In charge of the neu
Phone
+98 21 2272 4209
Email
ashkan2579@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
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 data will be published in such a way that the names of the people are not known and the people or data will be mentioned by the code
When the data will become available and for how long
after publish article
To whom data/document is available
researcher in univercity
Under which criteria data/document could be used
for new research or meta analysis
From where data/document is obtainable
dr Ashkan Irani emai: ashkan2579@yahoo.com
What processes are involved for a request to access data/document
After submitting the application and sending the proposal, it will be made available to the applicant by presenting it in the council of the Physical Medicine Research Center, after agreeing and fulfilling the necessary obligations to preserve and use the information only for the agreed research.
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