Using brain stimulation to help children with autism
Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder
This study is testing if a type of brain stimulation can help children and young adults with autism feel better by reducing symptoms like repetitive behaviors and hyperactivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT04446442 on ClinicalTrials.gov |
What this trial studies
This research investigates the safety and effects of transcranial direct current stimulation (tDCS) applied to the cerebellum in children and young adults diagnosed with autism spectrum disorder (ASD). The study will involve 60 participants aged 4-17, who will undergo a randomized, double-blind, controlled design to assess changes in symptoms such as repetitive behaviors and hyperactivity. Participants will be screened for eligibility and will complete various tasks to establish baseline behavioral measurements before receiving the intervention. The study aims to gather data on the potential therapeutic effects of tDCS on ASD symptoms.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-17 who have been diagnosed with autism spectrum disorder using the ADOS-2 assessment.
Not a fit: Patients with brain implants, epilepsy, or significant sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for managing symptoms of autism spectrum disorder in children.
How similar studies have performed: While the use of tDCS is a relatively novel approach in this context, preliminary studies have shown promise in similar applications for neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas and 1 other locations
- Children's Medical Center — Dallas, Texas, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Peter Tsai, MD, PhD — University of Texas Southwestern Medical Center
- Study coordinator: Peter Tsai, MD, PhD
- Email: peter.tsai@utsouthwestern.edu
- Phone: 214-648-3577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.