A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
New York State Institute for Basic Research
RECRUITING
Staten Island
Contact Information
Primary
J. Helen Yoo, Ph.D.
jhelen.yoo@opwdd.ny.gov
(929) 257-1695
Backup
Eric London, M.D.
naarlondon@gmail.com
(845) 459-5737
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2029-12
Participants
Target number of participants: 24
Treatments
Experimental: Active tDCS
Active stimulation first, then crossover to Sham stimulation. Each participant will receive BOTH sham and 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.
Sham_comparator: Sham tDCS
Sham stimulation first, then crossover to Active stimulation. Each participant will receive BOTH sham and 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.
Related Therapeutic Areas
Sponsors
Leads: New York State Institute for Basic Research

This content was sourced from clinicaltrials.gov