Non-invasive Brain Stimulation in Children With Autism
A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment.
There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG).
This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females between 5 and 12 years with autism
- Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
- Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
- Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.
Exclusion Criteria:
- Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
- Severe neurological disorders such as TBI, brain tumor, intracranial infection
- Seizure disorder with a seizure within the last two years
- Skull defect
- Peripheral blindness or deafness
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
- Acute skin disease
- History of magnetic or electrical stimulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active tDCS
[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. |
The anodal electrode will be placed over F3 using the international 10-20 EEG electrode placement system to target the left dorsolateral prefrontal cortex (DLPFC). The cathode electrode will be placed on the right dorsolateral prefrontal cortex. 40 stimulation sessions will be completed (20 active, 20 sham), each lasting 20 minutes per session at 1.0mA.
Sham tDCS
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Sham Comparator: Sham tDCS
[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. |
The anodal electrode will be placed over F3 using the international 10-20 EEG electrode placement system to target the left dorsolateral prefrontal cortex (DLPFC). The cathode electrode will be placed on the right dorsolateral prefrontal cortex. 40 stimulation sessions will be completed (20 active, 20 sham), each lasting 20 minutes per session at 1.0mA.
Sham tDCS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: Change measured once per month (at the end of each phase) for 5 months
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The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100
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Change measured once per month (at the end of each phase) for 5 months
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Change in Electrodncephalogram (EEG)
Time Frame: Change measured once per month (at the end of each phase) for 5 months
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Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed from 2-minute resting EEGs using a portable headset
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Change measured once per month (at the end of each phase) for 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy
Time Frame: Obtained once at the completion of the study (5 months after the start of the study)
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Individualized behavior data from ABA therapy
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Obtained once at the completion of the study (5 months after the start of the study)
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Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time Frame: Change measured once per month (at the end of each phase) for 5 months
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The PDDBI is a parent-reported questionnaire about the symptoms of ASD.
The PDDBI utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100.
The higher the Approach/Withdrawal Problems and the higher the Autism scores, the more severe the deficits.
The higher the Receptive/Expressive Social Communication scores, the better the competence in these areas
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Change measured once per month (at the end of each phase) for 5 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vineland Adaptive Behavior Scales (for demographic purposes)
Time Frame: Once during 4-week baseline for the entire study
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Parent reported daily living skills
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Once during 4-week baseline for the entire study
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Leiter-3 nonverbal intelligence assessment (for demographic purposes)
Time Frame: Once during 4-week baseline (if a similar test was not done in the past three years) for the entire study
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Nonverbal intelligence test
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Once during 4-week baseline (if a similar test was not done in the past three years) for the entire study
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Collaborators and Investigators
Investigators
- Principal Investigator: Barbie Zimmerman-Bier, M.D., Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2020000931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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