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Completed

NCT Number: NCT05491720

Electrical Brain Stimulation and Pharmacological Treatments in 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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The National Brain Mapping Laboratory (NBML)

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RisperiDONE 1 MG/ML

Drug

Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days

Transcranial Direct Current Stimulation

Device

Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days

Other names: tDCS

Placebo

Drug

Patients will receive placebo tablet (Galenus pharmaceutical company)

Sham Transcranial Direct Current Stimulation

Device

Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days

Primary outcomes

  1. Gilliam Autism Rating Scale (GADS)

    Time frame: 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

  2. verbal fluency task

    Time frame: up to 3 months after the intervention

    Performance in the verbal fluency task as an executive and language function task

  3. Theory of mind

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The National Brain Mapping Laboratory (NBML)

Other

Collaborators

  • Ardabil University of Medical Sciences
  • Leibniz Research Centre for Working Environment and Human Factors
  • University of Tehran

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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