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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • The National Brain Mapping Laboratory (NBML)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS group; 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.	Device: transcranial direct current stimulation; Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days; Other Names: tDCS; Drug: Placebo; Patients will receive placebo tablet (Galenus pharmaceutical company)
Experimental: Medication group; Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days	Drug: RisperiDONE 1 MG/ML; Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days; Device: sham transcranial direct current stimulation; Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Placebo Comparator: Control group; Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
verbal fluency task	Performance in the verbal fluency task as an executive and language function task	up to 3 months after the intervention
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

Collaborators and Investigators

• Sponsor: The National Brain Mapping Laboratory (NBML)
• Collaborators: Ardabil University of Medical Sciences; University of Tehran; Leibniz Research Centre for Working Environment and Human Factors

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: IR.ARUMS.REC.1395.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No