Cerebellar tDCS in Children With Autism Spectrum Disorder
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Brain implants, metal implants, pacemakers, or biomedical devices
Diagnosis of epilepsy
Hearing or visual impairments
History of brain injury
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
DeviceA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Full Administration of Transcranial Direct Current StimulationExperimental treatment 1 intervention
Group B: Sham Administration of Transcranial Direct Current StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment
Time frame
Post-Intervention up to one monthSecondary outcomes
1
Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The NEPSY-2 subtests include: Memory for Faces, Theory of Mind, and Affect Recognition. The NEPSY-2 subtests are designed to assess abilities related to memory, learning, and social perception.
Time frame
Pre-Intervention at 1 week and Post-Intervention at 1 hour2
Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. This will be assessed by Reading the Mind in the Eyes, a measure of complex mental state recognition.
Time frame
Pre-Intervention at 1 week and Post-Intervention at 1 hour3
Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The Triangle Animations/ Social Perception Task assesses Theory of Mind mental functions such as belief and intention.
Time frame
Pre-Intervention at 1 week and Post-Intervention at 1 hour4
Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior. The Cyberball/Social Ball Throwing Task assesses engagement in social interaction.
Time frame
Pre-Intervention at 1 week and Post-Intervention at 1 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov