About this trial
The purpose of this clinical trial is to investigate the effects of multiple sessions of transcranial direct current stimulation (tDCS) delivered while participants complete tasks that target social learning with high functioning adults with ASD and/or high traits of ASD.
The main question it aims to answer is:
What are the effects of multiple sessions of active compared to sham tDCS, with tDCS simultaneously paired with social learning tasks, from employing a within-subject, cross-over randomized controlled trial design?
Participants will:
* Complete a randomly assigned block of 5 sessions of active and a block of 5 sessions of sham tDCS, with a four-week break occurring between the two blocks. * Complete social learning tasks simultaneously during receipt of tDCS at each session (whether receiving active or sham tDCS). * Complete behavioral, physiological, and electrophysiological testing before and after each block of active or sham tDCS. * Complete a social validity questionnaire after completion of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-35 years
Proficient in English
Classification of autism or autism spectrum disorder on Autism Diagnostic Observation Scale, 2nd Edition (ADOS-2) or score of >= 17 on Autism Quotient (AQ)
Good or corrected vision and hearing
Disqualifiers
No known loss of consciousness for > 5 minutes
No immediate biological family members with a history of epilepsy or seizure disorder
No major medical needs (e.g., neurological disorders such as a seizure disorder; long-term illness)
No surgically implanted metal above the neck (example: metal pins or plates, cochlear implants, aneurysm clips, brain electrodes)
Trial design
Crossover
Treatments tested in this trial
Anodal tDCS + Social Learning
DeviceAnodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Placebo Anodal tDCS + Social Learning
BehavioralSocial learning tasks are completed on a computer and consist of viewing video modeling of social interactions, facial emotion detection practice, and videos for emotion and empathy learning.
Treatment groups
Trial outcomes
Primary outcomes
Measure of Emotional Distress - Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Emotional Distress - Anxiety (PEDA) A change in PEDA scores corresponds to a change in emotional distress and anxiety. Each question on the PEDA provides a 5-point scale where lower scores mean a better outcome.
Measure of Social Anxiety
Liebowitz Social Anxiety Scale (LSAS) The LSAS assesses the range of social interaction and performance situations that individuals with social anxiety may fear and/or avoid. Each two-part question of the LSAS provides a 4-point scale where lower scores mean a better outcome.
Measure of Social Anxiety/Anxiety
Vocal acoustic analysis measures changes in fundamental frequency (F0), which is an indicator of change in social anxiety/anxiety, where lower F0 means a better outcome.
Measure of Social Anxiety
Heart-Rate Variability (HRV) A change in HRV is an indicator of change in the level of social anxiety, where higher HRV means a better outcome.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of New Mexico
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator