Cerebellar tDCS in Children With Autism Spectrum Disorder

NCT04446442 | Recruiting

• 2 other identifiers: UTSW 022017-071W81XWH1910249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of tDCS associated side effects assessed by tDCS Safety Assessment

  Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment

  Post-Intervention up to one month

Secondary Outcomes (6)

• Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests

  Pre-Intervention at 1 week and Post-Intervention at 1 hour

• Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes

  Pre-Intervention at 1 week and Post-Intervention at 1 hour

• Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task

  Pre-Intervention at 1 week and Post-Intervention at 1 hour

• Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task

  Pre-Intervention at 1 week and Post-Intervention at 1 hour

• Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort

  Pre-Intervention at 1 week and Post-Intervention at 1 hour

Study Arms (2)

Full Administration of Transcranial Direct Current Stimulation

EXPERIMENTAL

Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.

Device: tDCS

Sham Administration of Transcranial Direct Current Stimulation

SHAM COMPARATOR

Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments.

Device: tDCS

Interventions

tDCS DEVICE

A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.

Full Administration of Transcranial Direct Current Stimulation; Sham Administration of Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Diagnosed with ASD and ADOS-2
• IQ Score no less than 70 (1.5 Standard Deviations below the mean)
• Language Level (Speech consists of, at minimum, flexible, spontaneous, simple, sentences)

You may not qualify if:

• Brain implants, metal implants, pacemakers, or biomedical devices
• Diagnosis of epilepsy
• Hearing or visual impairments
• History of brain injury
• Known brain abnormalities not associated with ASD

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (2)

Children's Medical Center

Dallas, Texas, 75235, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Peter Tsai, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Tsai, MD, PhD

CONTACT

214-648-3577; peter.tsai@utsouthwestern.edu

Amy Magallanes

CONTACT

214-648-5155; amy.magallanes@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: June 25, 2020
• Study Start: June 4, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)