Transcranial Direct Current Stimulation in Children With Autism
NCT07092280 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-02-23
Summary
Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice.
The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task.
tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.
Conditions
- Autism Spectrum Disorder
- Executive Dysfunction
Interventions
- DEVICE
-
Active tDCS
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method used to modulate cortical excitability, which produces facilitatory or inhibitory effects on behaviors. The anodal electrode will be positioned at F3 (using the international 10-20 EEG system) to target the left dorsolateral prefrontal cortex (DLPFC). The cathodal electrode will be placed over the right DLPFC. Participants will undergo 20 active stimulation sessions, each lasting 20 minutes at a continuous 1.0 mA intensity.
- DEVICE
-
Sham (No Treatment)
The anodal electrode will be positioned at F3 (according to the international 10-20 EEG system), targeting the left dorsolateral prefrontal cortex (DLPFC). The cathodal electrode will be placed over the right DLPFC. Participants will receive 20 sessions of sham stimulation, each 20 minutes long. At the start of each session, the current ramps up and remains active for 30 seconds. After 30 seconds, the current is DISCONTINUED (held at 0 mA) but the power indicator stays illuminated for the remainder of the 20-minute session to ensure effective blinding, as is standard in tDCS sham protocols
Sponsors & Collaborators
-
New York State Institute for Basic Research
lead OTHER_GOV
Principal Investigators
-
J. Helen Yoo, Ph.D. · New York State Institute for Basic Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 5 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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