Non-invasive Brain Stimulation for Autism
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants have stable medical and behavioral treatments for at least 4 weeks before and during the study. However, if you are taking certain medications, such as anti-seizure drugs, serotonin reuptake inhibitors, or medications affecting dopamine, norepinephrine, or NMDA receptors, you may be excluded from participating.
What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for autism?
Research shows that transcranial direct current stimulation (tDCS) can help improve sociability, behavior, health, and physical conditions in children with autism spectrum disorder (ASD). Studies found significant improvements in these areas after tDCS treatment compared to a control group, with no reported side effects.12345
Is transcranial direct current stimulation (tDCS) safe for humans?
How is transcranial direct current stimulation (tDCS) different from other treatments for autism?
Transcranial direct current stimulation (tDCS) is a unique, non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, such as the prefrontal and motor areas, which are associated with autism symptoms. Unlike medications, tDCS does not involve drugs and has shown potential improvements in sociability, behavior, and physical conditions in children with autism without reported side effects.12345
Research Team
Barbie Zimmerman-Bier, M.D.
Principal Investigator
Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)
Eligibility Criteria
This trial is for children aged 5-12 with autism, enrolled in an ABA program. They must have stable medical and behavioral treatments for at least a month before the study and be able to wear tDCS equipment after desensitization training. Children with metal implants, recent seizures, certain medication use (like serotonin reuptake inhibitors or dopamine affecting drugs), severe neurological issues, sensory impairments, or those on medications that might interfere with tDCS are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessments including Leiter-3 nonverbal intelligence and Vineland Adaptive Behavior Scales
Treatment
Participants receive 40 sessions of tDCS (20 active, 20 sham) during ABA therapy, each lasting 20 minutes
Follow-up
Participants are monitored for changes in executive function and ASD symptoms using BRIEF, PDDBI, and EEG
Treatment Details
Interventions
- Sham tDCS
- Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
- Depression
- Stroke rehabilitation
- Chronic pain management
- Research use for various neurological and psychiatric conditions including autism spectrum disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
New York State Institute for Basic Research
Collaborator
Boston Children's Hospital
Collaborator