Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491720
• Other study ID #: IR.ARUMS.REC.1395.20
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: November 2023
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 3, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	The National Brain Mapping Laboratory (NBML)	Tehran

Sponsors (4)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 3 months after the intervention
Primary	verbal fluency task	Performance in the verbal fluency task as an executive and language function task	up to 3 months after the intervention
Primary	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.	up to 3 months after the intervention