search
Back to results

Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Active
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
RisperiDONE 1 MG/ML
transcranial direct current stimulation
Placebo
sham transcranial direct current stimulation
Sponsored by
The National Brain Mapping Laboratory (NBML)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The National Brain Mapping Laboratory (NBML)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

tDCS group

Medication group

Control group

Arm Description

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.

Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days

Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
August 5, 2022
Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
search

1. Study Identification

Unique Protocol Identification Number
NCT05491720
Brief Title
Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
Official Title
Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
August 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Medication group
Arm Type
Experimental
Arm Description
Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.
Intervention Type
Drug
Intervention Name(s)
RisperiDONE 1 MG/ML
Intervention Description
Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo tablet (Galenus pharmaceutical company)
Intervention Type
Device
Intervention Name(s)
sham transcranial direct current stimulation
Intervention Description
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Primary Outcome Measure Information:
Title
Gilliam Autism Rating Scale (GADS)
Description
Score in the Gilliam Autism Rating Scale (GADS) Autism index scores: 69 or less = unlikely 70-84 = possible 85 or higher = very likely
Time Frame
up to 3 months after the intervention
Title
verbal fluency task
Description
Performance in the verbal fluency task as an executive and language function task
Time Frame
up to 3 months after the intervention
Title
Theory of mind
Description
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.
Time Frame
up to 3 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The National Brain Mapping Laboratory (NBML)
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

We'll reach out to this number within 24 hrs