Recruiting

tDCS

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05691283

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

trans cranial direct current stimulation (tDCS)

Sham

Study Details

Brief summary:

The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).

Conditions

Autism Spectrum Disorder

Study ID

NCT05691283

Start date

Jun 20, 2023

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician

Exclusion Criteria:

  • Pregnancy
  • Brain implants
  • Pacemakers
  • Any biomedical or metal implants in any part of body
  • Hearing or visual impairment
  • History of brain injury
  • Known brain or skull abnormality other than those that may be associated with ASD

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: transcranial direct current stimulation (tDCS), then sham stimulation

Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation

experimental: Sham stimulation, then transcranial direct current stimulation (tDCS)

Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation

Interventions

trans cranial direct current stimulation (tDCS)

Three weeks of 20-minute tDCS stimulation

Sham

Three weeks of sham stimulation

Primary outcome measure

  • Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [ Time Frame: Baseline ]
  • Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version [ Time Frame: Post Treatment (approx at 3 month) ]
  • Social behavior as measured by Cyberball/Social Ball Throwing Task [ Time Frame: Baseline ]
  • Social behavior as measured by Cyberball/Social Ball Throwing Task [ Time Frame: Post Treatment (approx at 3 month) ]
  • Sensorimotor behavior as measured by Grip Strength [ Time Frame: Baseline ]
  • Sensorimotor behavior as measured by Grip Strength [ Time Frame: Post Treatment (approx at 3 month) ]
  • Sensorimotor behavior as measured by Reach Task [ Time Frame: Baseline ]
  • Sensorimotor behavior as measured by Reach Task [ Time Frame: Post Treatment (approx at 3 month) ]
  • Sensorimotor behavior as measured by Sensory Profile-2 [ Time Frame: Baseline ]
  • Sensorimotor behavior as measured by Sensory Profile-2 [ Time Frame: Post Treatment (approx at 3 month) ]
  • Neurophysiological impacts as measured by Magnetoencephalography (MEG) [ Time Frame: Baseline ]
  • Neurophysiological impacts as measured by Magnetoencephalography (MEG) [ Time Frame: Post Treatment (approx at 3 month) ]
  • Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline ]
  • Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI) [ Time Frame: Post Treatment (approx at 3 month) ]

Central Contacts and Locations

Central contacts

Haley Walker

214-797-6454Autism@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dalls, Texas, United States, 75390-8568

Contacts

Haley Walker

Haley.walker@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Keywords

  • Children
  • Young adults
  • Autism Spectrum Disorder
  • Transcranial direct current stimulation
  • tDCS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-08-26.