Autism Spectrum Disorder
Conditions
Brief summary
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
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.
Interventions
DRUGRisperiDONE 1 MG/ML
Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
DEVICEtranscranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
DRUGPlacebo
Patients will receive placebo tablet (Galenus pharmaceutical company)
DEVICEsham transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Sponsors
Ardabil University of Medical Sciences
Leibniz Research Centre for Working Environment and Human Factors
University of Tehran
The National Brain Mapping Laboratory (NBML)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gilliam Autism Rating Scale (GADS) | up to 3 months after the intervention | Score in the Gilliam Autism Rating Scale (GADS) Autism index scores: 69 or less = unlikely 70-84 = possible 85 or higher = very likely |
| verbal fluency task | up to 3 months after the intervention | Performance in the verbal fluency task as an executive and language function task |
| Theory of mind | up to 3 months after the intervention | 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. |
Countries
Iran
Outcome results
None listed