Transcranial direct current stimulation plus ABA to boost language and executive skills in children with autism.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.