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Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

Sponsor
The National Brain Mapping Laboratory (NBML) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05491720
Collaborator
Ardabil University of Medical Sciences (Other), Leibniz Research Centre for Working Environment and Human Factors (Other), University of Tehran (Other)
45
Enrollment
1
Location
3
Arms
23.6
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: RisperiDONE 1 MG/ML
  • Device: transcranial direct current stimulation
  • Drug: Placebo
  • Device: sham transcranial direct current stimulation
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
Mar 15, 2022
Anticipated Study Completion Date :
Aug 3, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. verbal fluency task [up to 3 months after the intervention]

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

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The National Brain Mapping Laboratory (NBML) Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad Ali Salehinejad, Principal Investigator, The National Brain Mapping Laboratory (NBML)
    ClinicalTrials.gov Identifier:
    NCT05491720
    Other Study ID Numbers:
    • IR.ARUMS.REC.1395.20
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Autistic Disorder
    Autism Spectrum Disorder
    Child Development Disorders, Pervasive
    Risperidone

    Study Results

    No Results Posted as of Aug 8, 2022