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Non-invasive Brain Stimulation for Autism

JH
EB
Overseen ByEric B London, M.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and temporary side effects like itching, tingling, and headaches. However, there are warnings that it could potentially cause serious conditions, so caution is advised, especially for healthy individuals.16789

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

BZ

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

Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
, are required It is necessary to have stable medical and behavioural treatments for at least 4 weeks prior to and during the study.
Boys and girls between the ages of 5 and 12 who have autism.
See 1 more

Exclusion Criteria

You have a hole or opening in your skull.
You are taking medications that affect dopamine, such as drugs for Parkinson's disease or antipsychotic medications.
Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including Leiter-3 nonverbal intelligence and Vineland Adaptive Behavior Scales

1 week
1 visit (in-person)

Treatment

Participants receive 40 sessions of tDCS (20 active, 20 sham) during ABA therapy, each lasting 20 minutes

5 months
40 visits (in-person)

Follow-up

Participants are monitored for changes in executive function and ASD symptoms using BRIEF, PDDBI, and EEG

5 months
Monthly assessments

Treatment Details

Interventions

  • Sham tDCS
  • Transcranial Direct Current Stimulation (tDCS)
Trial OverviewThe trial tests if transcranial direct current stimulation (tDCS) can help improve learning when combined with applied behavior analysis (ABA). It involves low-level electrical neurostimulation aimed at enhancing brain function related to learning. Participants will receive either actual tDCS or a sham (placebo) version without active stimulation.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment2 Interventions
\[Active stimulation first, then crossover to Sham stimulation\] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy.
Group II: Sham tDCSPlacebo Group2 Interventions
\[Sham stimulation first, then crossover to Active stimulation\] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy.

Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Transcranial Direct Current Stimulation for:
  • Depression
  • Stroke rehabilitation
  • Chronic pain management
  • Research use for various neurological and psychiatric conditions including autism spectrum disorder
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Transcranial Direct Current Stimulation for:
  • Depression
  • Stroke rehabilitation
  • Chronic pain management
  • Research use for various neurological and psychiatric conditions including autism spectrum disorder
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Transcranial Direct Current Stimulation for:
  • 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

Trials
471
Recruited
81,700+

New York State Institute for Basic Research

Collaborator

Trials
7
Recruited
960+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+

Findings from Research

A systematic review of five studies on transcranial direct current stimulation (tDCS) in children with autism spectrum disorder (ASD) showed positive effects on reducing symptom severity, although the studies varied widely in design and sample size (1 to 20 participants).
Despite the encouraging preliminary evidence suggesting potential benefits, the overall quality of the studies is low, indicating a need for more rigorous randomized controlled trials to better understand the efficacy of tDCS in treating ASD.
Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review.Osรณrio, AAC., Brunoni, AR.[2019]
In a study involving 20 patients with autism, anodal transcranial direct current stimulation (tDCS) significantly reduced scores on the Childhood Autism Rating Scale (CARS) and the Autism Treatment Evaluation Checklist (ATEC), indicating improvements in autism symptoms.
Additionally, the Children's Global Assessment Scale (CGAS) showed a significant increase at 7 days post-treatment, suggesting that tDCS may enhance overall functioning in individuals with autism.
Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial.Amatachaya, A., Auvichayapat, N., Patjanasoontorn, N., et al.[2018]
Bilateral anodal transcranial direct current stimulation (tDCS) applied to the prefrontal and motor areas showed significant therapeutic effects in children with autism spectrum disorder (ASD), leading to improvements in sociability and behavioral health, as indicated by decreased scores on the autism treatment evaluation checklist (ATEC).
The study involved 50 children with ASD who underwent 10 sessions of tDCS, with no reported side effects, suggesting that tDCS is a safe and noninvasive method for potentially enhancing clinical outcomes in this population.
Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study.Hadoush, H., Nazzal, M., Almasri, NA., et al.[2021]

References

Transcranial direct current stimulation in children with autism spectrum disorder: a systematic scoping review. [2019]
Effect of anodal transcranial direct current stimulation on autism: a randomized double-blind crossover trial. [2018]
Therapeutic Effects of Bilateral Anodal Transcranial Direct Current Stimulation on Prefrontal and Motor Cortical Areas in Children with Autism Spectrum Disorders: A Pilot Study. [2021]
Long-term effects of transcranial direct current stimulation in the treatment of autism spectrum disorder: A randomized controlled trial. [2023]
Transcranial direct current stimulation for hyperactivity and noncompliance in autistic disorder. [2019]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]