Transcranial direct current stimulation plus ABA to boost language and executive skills in children with autism.
A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
This project will test whether adding low-level electrical brain stimulation (tDCS) to applied behavior analysis helps children ages 5–12 with autism learn language and executive function skills better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | New York State Institute for Basic Research Government |
| Locations | 1 site (Staten Island, New York) |
| Trial ID | NCT07092280 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, sham-controlled crossover trial enrolling 20 children with autism aged 5–12 who are already receiving ABA supervised by a BCBA. Each participant will receive 40 bi-frontal tDCS sessions (20 active, 20 sham) at 1 milliamp for 20 minutes while ABA teaching is delivered, with the anode at F3 and cathode at F4. Outcomes include measures of executive functioning and core ASD symptoms, monitored with behavioral tests and EEG. Eligibility requires stable medical/behavioral treatment and the ability to tolerate tDCS after a week-long desensitization period.
Who should consider this trial
Good fit: Children with autism aged 5–12 who are enrolled in an ABA program supervised by a BCBA, on stable treatments for at least 4 weeks, and able to tolerate tDCS are ideal candidates.
Not a fit: Children with implanted metal devices, recent seizures, severe neurological disorders, skull defects, peripheral blindness or deafness, or those on medications likely to alter tDCS effects are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, combining tDCS with ABA could speed or improve the acquisition of language and executive functioning skills for some children with autism.
How similar studies have performed: Small, preliminary studies of tDCS in ASD and related conditions have shown promising but mixed results, so the approach is still experimental in children.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Staten Island, New York
- New York State Institute for Basic Research — Staten Island, New York, United States (Recruiting)
Study contacts
- Principal investigator: J. Helen Yoo, Ph.D. — New York State Institute for Basic Research
- Study coordinator: J. Helen Yoo, Ph.D.
- Email: jhelen.yoo@opwdd.ny.gov
- Phone: (929) 257-1695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.