NCT05491720

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

August 4, 2022

Last Update Submit

November 3, 2023

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

tDCS group

EXPERIMENTAL

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 stimulationDrug: Placebo

Medication group

EXPERIMENTAL

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

Drug: RisperiDONE 1 MG/MLDevice: sham transcranial direct current stimulation

Control group

PLACEBO COMPARATOR

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

Drug: PlaceboDevice: sham transcranial direct current stimulation

Interventions

RisperiDONE 1 MG/MLDRUG

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

Medication group
transcranial direct current stimulationDEVICE

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

Also known as: tDCS
tDCS group
PlaceboDRUG

Patients will receive placebo tablet (Galenus pharmaceutical company)

Control grouptDCS group
sham transcranial direct current stimulationDEVICE

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

Control groupMedication group

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
  • being 6-16 years old
  • providing written informed consent signed by parents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Brain Mapping Laboratory (NBML)

Tehran, Iran

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

RisperidoneTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsElectric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

August 15, 2020

Primary Completion

March 15, 2022

Study Completion

August 3, 2022

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

IR(1)