Recruiting

Cerebellar TDCS

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04446442

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Accepted

Interventions

tDCS

Study Details

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

Study ID

NCT04446442

Start date

Jun 4, 2019

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 4-17 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Full Administration of Transcranial Direct Current Stimulation

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.

sham comparator: Sham Administration of Transcranial Direct Current Stimulation

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.

Interventions

tDCS

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.

Primary outcome measure

  • Incidence of tDCS associated side effects assessed by tDCS Safety Assessment [ Time Frame: Post-Intervention up to one month ]

Central Contacts and Locations

Central contacts

Peter Tsai, MD, PhD

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

Amy Magallanes

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

Locations

Children's Medical Center

Recruiting

Dallas, Texas, United States, 75235

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

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 2026-06-04.