]>
IRCT20190917044793N1 IRCT 2020-10-15 Ardabil University of Medical Sciences Transcranial electrical stimulation and pharmacological interventions in Autism Spectrum Disorder Comparing the effectiveness of transcranial direct current stimulation treatment with common pharmacological treatments in autistic children’s symptoms 2019-10-02 anticipated 45 Complete https://irct.ir/trial/42278 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method will be “simple randomization” (Suresh, 2011). This method randomization will be based on a single sequence of random assignments and include complete randomness of the assignment of patients to intervention groups (active tDCS group, pharmacology group, control group). Randomization will be done using an online website dedicated to randomizing sample size (https://www.randomizer.org/). By specifying the number of groups (n=3), the number of participants per group (n = 15), and the range of sample (1-45), participants will be randomly assigned to each group. Participants' code (1-45) will be randomly determined using draw. 45 children aged 6 to 16 with autism spectrum disorder that will be referred to the psychiatric clinic of Fatemi Hospital in Ardabil will receive one code upon referral using draw. Also, to prevent selective bias, the randomization method (for participants assignment) will be used and furthermore, concealment of random allocation will be applied, Blinding description: The present study has a single-blind design. The care providers and outcome assessors are not aware of any type of pharmacological intervention or the state of electrical stimulation in patients. The investigators who determine intervention groups are independent from those experimenters who apply interventions and those who do the measurements and this will guarantee experimenters blindness for the electrical stimulation group (Gandinga et al., 2006) . For the patients, except those who are dedicated to pharmacological intervention, others in the electrical stimulation groups and control group are blind to the intervention. Patients in the real stimulation group, will not be aware of the stimulation condition (i.e., anodal stimulation vs sham stimulation). In patients assigned to control group, electrical stimulation includes 60 seconds of ramping up and down which induce sensations like the real stimulation, and participants are not expected to realize sham stimulation (Gandinga et al., 2006). These patients will be blind to the type of prescription drug as well as Risperidone and placebo are prepared entirely in one form (in terms of color, odor, and appearance). 3 Autism. Intervention 1: Intervention Group 1: transcranial direct-current stimulation using an anodal electrode will be placed over left F3 and cathodal electrodes over right supraorbital F2 for 10 consecutive days, stimulation intensity will be 1.5 mA for 20 min per session. Additionally, they, along with electrical stimulation, will receive two placebo tablet 1 mg (Jalinoos Pharmaceutical company) per day (morning and noon). Measurements will take place before the intervention, and in 5, 10, 30, and 90 days after the intervention. Intervention 2: Intervention Group 2: The pharmacological group will be examined by a child psychiatrist and undergo baseline measurement (pre-test). Then, as prescribed by specialists, 2 daily (morning and noon) tablets of 1 mg risperidone (manufactured by pharmaceutical Sobhan) will be taken for 10 consecutive days. Outcome measurements will be similar to the intervention group 1 and will take place before the intervention, after 5, 10, 30, and 90 days. Intervention 3: Control group: Participants in this group will receive a placebo tablet and concurrent sham tDCS with the same pharmacological regiment and stimulation montage for 10 days. Outcome measurements will take place before the intervention, after 5, 10, 30, and 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of the participants' personal characteristics
public Dr. Parviz Molavi
Department of Psychiatry, Fatemi Hospital, Sareyn station, Ardabil
Ardabil Iran (Islamic Republic of) 5614733775 +98 45 3323 2520 p.molavi@yahoo.com Ardabil University of Medical Sciences scientific Mohammad Ali Salehinejad
Institute of Cognitive & Brain Sciences, Shahid Beheshti University, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2243 1616 salehinejadmohammadali@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of autism spectrum disorder by a child psychiatrist being 6-16 years old required written iformed consent signed by parents 6 years 16 years Both comorbidity with other neurodevelopmental disorders and neurological diseases F84.0 Autistic disorder Treatment - Devices Treatment - Drugs Placebo Intervention Group 1: transcranial direct-current stimulation using an anodal electrode will be placed over left F3 and cathodal electrodes over right supraorbital F2 for 10 consecutive days, stimulation intensity will be 1.5 mA for 20 min per session. Additionally, they, along with electrical stimulation, will receive two placebo tablet 1 mg (Jalinoos Pharmaceutical company) per day (morning and noon). Measurements will take place before the intervention, and in 5, 10, 30, and 90 days after the intervention. Intervention Group 2: The pharmacological group will be examined by a child psychiatrist and undergo baseline measurement (pre-test). Then, as prescribed by specialists, 2 daily (morning and noon) tablets of 1 mg risperidone (manufactured by pharmaceutical Sobhan) will be taken for 10 consecutive days. Outcome measurements will be similar to the intervention group 1 and will take place before the intervention, after 5, 10, 30, and 90 days. Control group: Participants in this group will receive a placebo tablet and concurrent sham tDCS with the same pharmacological regiment and stimulation montage for 10 days. Outcome measurements will take place before the intervention, after 5, 10, 30, and 90 days. Score in the Gilliam autism rating scale. Timepoint: before intervention and 5, 10 , 30 and 90 days after intervention. Method of measurement: Gilliam autism rating scale. Performance in the verbal fluency task. Timepoint: before intervention and 5, 10 , 30 and 90 days after intervention. Method of measurement: Verbal fluency task. Score in the theory of mind test. Timepoint: before intervention and 5, 10 , 30 and 90 days after intervention. Method of measurement: Theory of Mind Test (ToMT). Ardabil University of Medical Sciences Approved 2017-03-07 Ethics Committee of Ardabil University of Medical Sciences End of University Street, Ardabil University of Medical Sciences Ardabil Ardabil Iran (Islamic Republic of)