Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

Phase 1

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: transcranial direct current stimulation; Drug: Placebo; Drug: RisperiDONE 1 MG/ML; Device: sham transcranial direct current stimulation

• Registration Number: NCT05491720
• Lead Sponsor: The National Brain Mapping Laboratory (NBML)

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.

Study Timeline

• Study Start: 2020-08-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-08-03
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS group	transcranial direct current stimulation	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.
Control group	Placebo	Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.
Medication group	sham transcranial direct current stimulation	Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
Medication group	RisperiDONE 1 MG/ML	Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
tDCS group	Placebo	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.
Control group	sham transcranial direct current stimulation	Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.

Primary Outcome Measures

Name	Time	Method
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
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.
verbal fluency task	up to 3 months after the intervention	Performance in the verbal fluency task as an executive and language function task

Trial Locations

Locations (1)

The National Brain Mapping Laboratory (NBML); 🇮🇷 Tehran, Iran, Islamic Republic of