tDCS for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism+1 MoretDCS - Device
Eligibility
4 - 17
All Sexes
What conditions do you have?
Select

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

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

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: Device
Sham Administration of Transcranial Direct Current Stimulation
Device
ShamComparator Group · 1 Intervention: tDCS · Intervention Types: Device
Treatment
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?
Pennsylvania40.0%
Texas20.0%
New York20.0%
Other20.0%
How old are they?
< 1866.7%
18 - 6533.3%
What site did they apply to?
Children's Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%