Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

Study Overview
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Brief Summary
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This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder

Detailed Description
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45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.

Official Title
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Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: RisperiDONE 1 MG/ML
* Device: transcranial direct current stimulation
* Drug: Placebo
* Device: sham transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist being 6-16 years old providing written informed consent signed by parents Exclusion Criteria: comorbidity with other neurodevelopmental disorders comorbidity with other neurological disorders previous history of neurosurgery presence of any ferromagnetic metal in the head implanted medical devices in the head or neck region history of noncontrolled epilepsy with seizures in the last year

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS group<br>TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the left dorsolateral prefrontal cortex and cathodal electrode will be placed over the right supraorbital area. | Device: transcranial direct current stimulation<br>* Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days<br>* Other names: tDCS;Drug: Placebo<br>* Patients will receive placebo tablet (Galenus pharmaceutical company)<br>|
| Experimental: Medication group<br>Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days | Drug: RisperiDONE 1 MG/ML<br>* Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days<br>Device: sham transcranial direct current stimulation<br>* Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days<br>|
| Placebo Comparator: Control group<br>Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days. | Drug: Placebo<br>* Patients will receive placebo tablet (Galenus pharmaceutical company)<br>Device: sham transcranial direct current stimulation<br>* Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gilliam Autism Rating Scale (GADS) | Score in the Gilliam Autism Rating Scale (GADS) Autism index scores: 69 or less = unlikely 70-84 = possible 85 or higher = very likely | up to 3 months after the intervention | 
| verbal fluency task | Performance in the verbal fluency task as an executive and language function task | up to 3 months after the intervention | 
| Theory of mind | Score in the Theory of Mind Test (ToMT) Score range of subscales 1 to 3, is 0-20, 0-13, and 0-5, respectively and the total score range is 0-38. | up to 3 months after the intervention |