NCT07092280 · New York State Institute for Basic Research
Transcranial Direct Current Stimulation in Children With Autism
(tDCS)
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
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
The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100
Change in Electrodncephalogram (EEG)
Time frame: Change measured once per month (at the end of each phase) for 5 months
Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed from 2-minute resting EEGs using a portable headset
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females between 5 and 12 years with autism
- Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
- Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
- Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.
Exclusion criteria
- Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
- Severe neurological disorders such as TBI, brain tumor, intracranial infection
- Seizure disorder with a seizure within the last two years
- Skull defect
- Peripheral blindness or deafness
- Medication that might affect tDCS: There have been a few studies concerning the effect of various medications on tDCS. Some may block and others may enhance the effects depending on many factors. The assay used to test these medications was its effect on the motor cortex after stimulation and this may not apply to our montages, however, in order to minimize the chances of having medication affect our results, participants taking the following medications will be excluded:
- Na or Ca channel blockers which will include all anti-seizure medications
- Medications that affect the NMDA receptors including dextromethorphan, cycloserine
- Serotonin reuptake inhibitors
- Dopamine stimulating or blocking medications including pergolide, bromocriptine and all antipsychotic medications
- Norepinephrine stimulating or blocking agents including propranolol and the stimulants
- Drugs that can lower seizure threshold \[imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline\]
- Barbiturates, benzodiazepines, meprobamate, chloral hydrate in the past 4 weeks
- Acute skin disease
- History of magnetic or electrical stimulation
Where
- Staten Island, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations