NCT07092280 Transcranial Direct Current Stimulation in Children With Autism
| NCT ID | NCT07092280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York State Institute for Basic Research |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-04-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
J. Helen Yoo, Ph.D.
PRINCIPAL INVESTIGATOR
New York State Institute for Basic Research
Frequently Asked Questions
Who can join the NCT07092280 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07092280 currently recruiting?
Yes, NCT07092280 is actively recruiting participants. Contact the research team at jhelen.yoo@opwdd.ny.gov for enrollment information.
Where is the NCT07092280 trial being conducted?
This trial is being conducted at Staten Island, United States.
Who is sponsoring the NCT07092280 clinical trial?
NCT07092280 is sponsored by New York State Institute for Basic Research. The principal investigator is J. Helen Yoo, Ph.D. at New York State Institute for Basic Research. The trial plans to enroll 24 participants.