NCT05491720

Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The National Brain Mapping Laboratory (NBML) · Academic / Other
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	RisperiDONE 1 MG/ML	Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
DEVICE	transcranial direct current stimulation	Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
DRUG	Placebo	Patients will receive placebo tablet (Galenus pharmaceutical company)
DEVICE	sham transcranial direct current stimulation	Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days

Timeline

• Start date: 2020-08-15
• Primary completion: 2022-03-15
• Completion: 2022-08-03
• First posted: 2022-08-08
• Last updated: 2023-11-07

Locations

1 site across 1 country: Iran