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IRCT20150223021208N2 IRCT 2020-11-20 Iran University of Medical Sciences Comparing the effect of transcranial direct current stimulation (tDCS) with cognitive rehabilitation in autism transcranial direct current stimulation (tDCS); autism spectrum disorder (ASD) 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 2020-12-21 anticipated 40 Complete https://irct.ir/trial/52247 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, 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. N/A Autism spectrum disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is If It means SPSS data sheet, no at the moment; because we decide to publish several reports that the time period will be long and unpredictable.
public Dr Samaneh Karamali Esmaili
Department of Occupational therapy, School of Rehabilitation, Madadkaran alley, Shah-Nazari Street, Mirdamad Boulevard, Tehran,
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 samauneh.esmaeili@gmail.com Iran University of Medical Sciences scientific Dr Mehdi Alizadeh Zarei
Department of Occupational Therapy, School of Rehabilitation, Madadkaran Alley, Shah-Nazari Street, Mirdamad Boulevard, Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 mehdii.alizadeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 8 years 14 years Both comorbid neurological disorder receiving the tDCS during the previous year F84.0 Autistic disorder Treatment - Devices Rehabilitation Rehabilitation Rehabilitation 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. 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. 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. 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. 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. Occupational performance. Timepoint: before, after, and 1 month after the intervention (follow-up). Method of measurement: Canadian Occupational Performance Measure (COPM). Iran University of Medical Sciences Approved 2019-04-07 Iran University of Medical Sciences Shahid hemmat highway Tehran Tehran Iran (Islamic Republic of)