Transcranial Direct Current Stimulation in Children With Autism

NCT07092280 | Recruiting FDA Device

• 1 other identifier: NKI2024-46-IBRDD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

transcranial direct current stimulation; applied behavior analysis

Outcome Measures

Primary Outcomes (2)

• Change in the Behavior Rating Inventory of Executive Function (BRIEF)

  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 measured once per month (at the end of each phase) for 5 months

• Change in Electrodncephalogram (EEG)

  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

  Change measured once per month (at the end of each phase) for 5 months

Secondary Outcomes (2)

• Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)

  Change measured once per month (at the end of each phase) for 5 months

• Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy

  Obtained once at the completion of the study (5 months after the start of the study).

Other Outcomes (2)

• Vineland Adaptive Behavior Scales (for demographic purposes)

  Once during 4-week baseline for the entire study.

• Leiter-3 nonverbal intelligence assessment (for demographic purposes)

  Once during 4-week baseline (if a similar test was not done in the past three years) for the entire study.

Study Arms (2)

Active tDCS

EXPERIMENTAL

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.

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

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.

Device: Sham (No Treatment)

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.

Active tDCS

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

Sham tDCS

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Institute for Basic Research: lead

Study Sites (1)

New York State Institute for Basic Research

Staten Island, New York, 10314, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• J. Helen Yoo, Ph.D.

  New York State Institute for Basic Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Helen Yoo, Ph.D.

CONTACT

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

Eric London, M.D.

CONTACT

(845) 459-5737; naarlondon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: sham vs. active transcranial direct current stimulation (tDCS)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist; Head of Applied Behavior Analysis Laboratory

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Start date: January 2026 End date: December 2029
• Access Criteria: Researchers engaging in independent scientific research will be provided IPD via email.

Locations

US (1)