Recruiting

tDCS & ABA

Sponsor:

New York State Institute for Basic Research

Code:

NCT07092280

Conditions

Autism Spectrum Disorder

Executive Dysfunction

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Active tDCS

Sham (No Treatment)

Study Details

Brief 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

Study ID

NCT07092280

Start date

Apr 1, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females between 5 and 12 years with autism
2. Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
3. Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
4. Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.

Exclusion Criteria:

1. Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
2. Severe neurological disorders such as TBI, brain tumor, intracranial infection
3. Seizure disorder with a seizure within the last two years
4. Skull defect
5. Peripheral blindness or deafness
6. 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
7. Acute skin disease
8. History of magnetic or electrical stimulation

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 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 ]
  • Change in Electrodncephalogram (EEG) [ Time Frame: Change measured once per month (at the end of each phase) for 5 months ]

Central Contacts and Locations

Central contacts

J. Helen Yoo, Ph.D.

(929) 257-1695jhelen.yoo@opwdd.ny.gov

Eric London, M.D.

(845) 459-5737naarlondon@gmail.com

Locations

New York State Institute for Basic Research

Recruiting

Staten Island, New York, United States, 10314

Contacts

J. Helen Yoo, Ph.D.

929-257-1695jhelen.yoo@opwdd.ny.gov

More Information

Sponsor

New York State Institute for Basic Research

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • transcranial direct current stimulation
  • applied behavior analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York State Institute for Basic Research on 2026-02-23.