Transcranial Direct Current Stimulation in Children With Autism

Part of paid clinical trials in Staten Island, New York.

Sponsor
New York State Institute for Basic Research
Study ID
NCT07092280
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Active tDCS — DEVICE
    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.
  • Sham (No Treatment) — DEVICE
    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

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active tDCS
    Active stimulation first, then crossover to Sham stimulation. Each participant will receive BOTH sham and active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy.
  • Sham Comparator: Sham tDCS
    Sham stimulation first, then crossover to Active stimulation. Each participant will receive BOTH sham and active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy.

Primary Outcome Measure

Change in the Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Change measured once per month (at the end of each phase) for 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Institute for Basic ResearchStaten IslandNew York10314
J. Helen Yoo, Ph.D.
[email protected]
929-257-1695

Find similar trials in Staten Island, NY

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
New York State Institute for Basic Research· Staten Island, NY

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