Autism Spectrum DisordertDCSNCT07092280
Transcranial Direct Current Stimulation in Children With Autism
A study testing Active tDCS in people with Autism Spectrum Disorder and Executive Dysfunction, run by New York State Institute for Basic Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Executive Dysfunction
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York State Institute for Basic Research
Staten Island, New York, 10314
J. Helen Yoo, Ph.D., 929-257-1695, jhelen.yoo@opwdd.ny.gov
About this study
Official title: A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
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.
Read the detailed description
Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment.
There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG).
This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.
- Conditions
- Autism Spectrum Disorder, Executive Dysfunction
- Being tested
- Active tDCS, Sham (No Treatment)
- Keywords
- transcranial direct current stimulation, applied behavior analysis
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
The PDDBI is a parent-reported questionnaire about the symptoms of ASD. The PDDBI utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100. The higher the Approach/Withdrawal Problems and the higher the Autism scores, the more severe the deficits. The higher the Receptive/Expressive Social Communication scores, the better the competence in these areas
Measured: 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
Individualized behavior data from ABA therapy. Individualized treatment data may be measured as: response rate per minute/hour/day, percent accuracy, percent interval, and percent correct.
Measured: Obtained once at the completion of the study (5 months after the start of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Apr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Institute for Basic Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Helen Yoo, New York State Institute for Basic Research
- Investigators
- J. Helen Yoo, Ph.D., Principal investigator, New York State Institute for Basic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092280
- Sponsor's protocol ID
- NKI2024-46-IBRDD
- Acronym
- tDCS
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact jhelen.yoo@opwdd.ny.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07092280
- Acronym / sponsor ID
- tDCS / NKI2024-46-IBRDD
- Conditions
- Autism Spectrum Disorder, Executive Dysfunction
- Keywords
- transcranial direct current stimulation, applied behavior analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- New York State Institute for Basic ResearchOther government
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment.
There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG).
This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSActive 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 tDCS | Sham comparator | Device: Sham (No Treatment)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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSTranscranial 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 | Active tDCS |
| 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 | Device | Sham tDCS |
Primary outcome
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
2 secondary outcomes
Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time frame: 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
Time frame: Obtained once at the completion of the study (5 months after the start of the study).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact jhelen.yoo@opwdd.ny.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Helen Yoo, Ph.D. principal investigator
New York State Institute for Basic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Autism Spectrum Disorder and Executive Dysfunction, run by New York State Institute for Basic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Helen Yoo, Ph.D. ((929) 257-1695, jhelen.yoo@opwdd.ny.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.