Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

The National Brain Mapping Laboratory (NBML)

Status and phase: Completed; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Device: transcranial direct current stimulation; Drug: Placebo; Drug: RisperiDONE 1 MG/ML; Device: sham transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05491720

IR.ARUMS.REC.1395.20

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

tDCS group

Experimental group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

Drug: Placebo

Medication group

Experimental group

Description:

Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days

Treatment:

Drug: RisperiDONE 1 MG/ML

Device: sham transcranial direct current stimulation

Control group

Placebo Comparator group

Description:

Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.

Treatment:

Drug: Placebo

Device: sham transcranial direct current stimulation