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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05491720
Other study ID # IR.ARUMS.REC.1395.20
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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