Study Summary
This trial will investigate whether tDCS to the cerebellum is safe and effective in treating symptoms of ASD such as repetitive behaviors and hyperactivity.
Eligible Conditions
- Autism
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Pre-Intervention at 1 week and Post-Intervention at 1 week and 1 month
Post-Intervention up to one month
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
Week 1
Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort
Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests
Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes
Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task
Month 1
Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Full Administration of Transcranial Direct Current Stimulation
1 of 2
Sham Administration of Transcranial Direct Current Stimulation
1 of 2
Experimental Treatment
Non-Treatment Group
60 Total Participants · 2 Treatment Groups
Primary Treatment: tDCS · Has Placebo Group · N/A
Full Administration of Transcranial Direct Current Stimulation
Device
Experimental Group · 1 Intervention: tDCS · Intervention Types: DeviceSham Administration of Transcranial Direct Current Stimulation
Device
ShamComparator Group · 1 Intervention: tDCS · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~730
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention at 1 week and post-intervention at 1 week and 1 month
Who is running the clinical trial?
United States Department of DefenseFED
779 Previous Clinical Trials
202,359 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
953 Previous Clinical Trials
608,686 Total Patients Enrolled
Peter Tsai, MD, PhDPrincipal Investigator - University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
Eligibility Criteria
Age 4 - 17 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The person has been diagnosed with ASD (Autism Spectrum Disorder) and ADOS-2.
If you want to be in the gifted program, your IQ score must be at least 70
The text consists of, at a minimum, flexible, spontaneous, and simple sentences.
Who else is applying?
What state do they live in?
| Pennsylvania | 40.0% |
| Texas | 20.0% |
| New York | 20.0% |
| Other | 20.0% |
How old are they?
| < 18 | 66.7% |
| 18 - 65 | 33.3% |
What site did they apply to?
| Children's Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 66.7% |
| Did not meet criteria | 33.3% |
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Conditions
Cancer Related
Treatments