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| Name | Class |
|---|---|
| Ardabil University of Medical Sciences | OTHER |
| Leibniz Research Centre for Working Environment and Human Factors | OTHER |
| University of Tehran | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS group | Experimental | 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. |
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| Medication group | Experimental | Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days |
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| Control group | Placebo Comparator | Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RisperiDONE 1 MG/ML | Drug | Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Brain Mapping Laboratory (NBML) | Tehran | Iran |
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| transcranial direct current stimulation | Device | Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days |
|
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| Placebo | Drug | Patients will receive placebo tablet (Galenus pharmaceutical company) |
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| sham transcranial direct current stimulation | Device | Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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