Transcranial Direct Current Stimulation in Children With Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorNew York State Institute for Basic Research
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Active tDCS
DeviceTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation method used to modulate cortical excitability, which produces facilitatory or inhibitory effects on behaviors. The anodal electrode will be positioned at F3 (using the international 10-20 EEG system) to target the left dorsolateral prefrontal cortex (DLPFC). The cathodal electrode will be placed over the right DLPFC. Participants will undergo 20 active stimulation sessions, each lasting 20 minutes at a continuous 1.0 mA intensity.
Sham (No Treatment)
DeviceThe anodal electrode will be positioned at F3 (according to the international 10-20 EEG system), targeting the left dorsolateral prefrontal cortex (DLPFC). The cathodal electrode will be placed over the right DLPFC. Participants will receive 20 sessions of sham stimulation, each 20 minutes long. At the start of each session, the current ramps up and remains active for 30 seconds. After 30 seconds, the current is DISCONTINUED (held at 0 mA) but the power indicator stays illuminated for the remainder of the 20-minute session to ensure effective blinding, as is standard in tDCS sham protocols
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Behavior Rating Inventory of Executive Function (BRIEF)
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
Time frame
Change measured once per month (at the end of each phase) for 5 months2
Change in Electrodncephalogram (EEG)
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
Time frame
Change measured once per month (at the end of each phase) for 5 monthsSecondary outcomes
1
Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
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
Time frame
Change measured once per month (at the end of each phase) for 5 months2
Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy
Individualized behavior data from ABA therapy. Individualized treatment data may be measured as: response rate per minute/hour/day, percent accuracy, percent interval, and percent correct.
Time frame
Obtained once at the completion of the study (5 months after the start of the study).Other outcomes
1
Vineland Adaptive Behavior Scales (for demographic purposes)
Parent reported daily living skills. Higher scores indicate better competence. The possible range for these scores is typically from 20 to 160 with a mean of 100 and a standard deviation of 15.
Time frame
Once during 4-week baseline for the entire study.2
Leiter-3 nonverbal intelligence assessment (for demographic purposes)
Nonverbal intelligence test. Higher scores indicate better competence, with a mean of 100 and a standard deviation of 15. Scores can range from Extremely Low (69 and below) to Very Superior (130+).
Time frame
Once during 4-week baseline (if a similar test was not done in the past three years) for the entire study.Sponsors and contacts
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Source ClinicalTrials.gov