Non-invasive Brain Stimulation in Children With Autism
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 🦠 Child Autism
🗓️ Study Start (Actual) 1 February 2022
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 December 2025
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Brunswick, New Jersey, United States

📋 Eligibility Criteria

Description

    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:
    • 1. Na or Ca channel blockers which will include all anti-seizure medications
    • 2. Medications that affect the NMDA receptors including dextromethorphan, cycloserine
    • 3. Serotonin reuptake inhibitors
    • 4. Dopamine stimulating or blocking medications including pergolide, bromocriptine and all antipsychotic medications
    • 5. Norepinephrine stimulating or blocking agents including propranolol and the stimulants
    • 6. Drugs that can lower seizure threshold \[imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline\]
    • 7. Barbiturates, benzodiazepines, meprobamate, chloral hydrate in the past 4 weeks
    • 7. Acute skin disease
    • 8. History of magnetic or electrical stimulation
Ages Eligible for Study: 5 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 September 2021
  • First Submitted that Met QC Criteria 2 November 2021
  • First Posted 3 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024