Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

The National Brain Mapping Laboratory (NBML)45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

RisperiDONE 1 MG/MLDRUG

Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days

transcranial direct current stimulationDEVICE

Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days

PlaceboDRUG

Patients will receive placebo tablet (Galenus pharmaceutical company)

Eligibility

Sex: ALLMin age: 7 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

The National Brain Mapping Laboratory (NBML)

Tehran, Iran

Outcomes

Primary Outcomes

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

Time frame: up to 3 months after the intervention

verbal fluency task

Performance in the verbal fluency task as an executive and language function task

Time frame: 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.

Time frame: up to 3 months after the intervention

Data from ClinicalTrials.gov

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