An interventional study of Anodal tDCS + Social Learning and Placebo Anodal tDCS + Social Learning in Autism Spectrum Disorder and Autism or Autistic Traits, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
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:
Our long-term goal is to develop safe and effective treatments to reduce negative symptoms of social communication impairments to improve overall quality of life. Our central hypotheses are (1) active, anodal tDCS over the right temporoparietal junction (rTPJ) paired with social learning activities will result in improved performance on behavioral and physiological measures, when compared to sham stimulation, (2) these improvements in performance will be correlated with changes in electrophysiological measures that contribute to successful participant social alignment after receipt of anodal tDCS, such as reductions in spectral alpha power (8-12Hz), which has been robustly associated with accurate internal modeling of sensorimotor activity during action comprehension and speech perception, and (3) improvements in performance on social measures will be accompanied by power reductions in theta oscillations (4-8Hz), which arise from prefrontal cortices and support context-specific cognitive control.
Specific Aim 1: Determine the effects of multiple sessions of active compared to sham tDCS. This aim will employ a within-subject, cross-over randomized controlled trial (RCT) design to explore the effects of 5 sessions of active vs. 5 sessions of sham tDCS on behavioral, physiological, and electrophysiological measures with autistic adults or adults with high traits of autism.
Objective 1: The development of improved stimulation protocols
While even a single session of tDCS has been shown to improve performance on social measures with adults diagnosed with autism spectrum disorder (ASD), recent work with children with ASD has shown that increasing the number of sessions from one to even five produces positive effects that are retained for up to one year, even when tDCS was not paired with a task. Importantly, it has been shown that pairing a task with the receipt of tDCS improves results when compared to delivering tDCS without a task. However, the majority of literature on the use of tDCS with adults with ASD has been restricted to studies examining a low number of sessions and/or tDCS paired with no task or tasks that are unrelated to treating the core diagnostic social impairments of ASD. This reinforces the need for research examining multiple sessions of tDCS paired with social interventions that are relevant to core diagnostic social impairments in autistic adults or adults with high traits of autism.
Objective 2: The improvement of social communication and social alignment in autistic adults or adults with high traits of autism
Successful social communication is a complex social process that not only requires the expression and reception of verbal speech, but also the modification and coordination of many behaviors to achieve social alignment. Social alignment is a mostly unconscious phenomenon in which people become more similar to a conversation partner by adjusting communication features such as vocal speech prosody (patterns of voice stress or intonation), facial expressions, and gestures.It is also suggested that social alignment reduces the burden placed on the cognitive system, thus making social interactions easier, and possibly less anxiety filled. Autistic individuals have significantly lower social alignment when compared to their neurotypical peers.
Of great interest is also capitalizing on the rTPJ's role in social alignment because of the rTPJ's participation in using sensory information (including visual and auditory) to evaluate self against others and in mediating embodied processes relevant to perspective taking (such as facial expression and gesture). Consequently, the proposed project has significance in its approach for investigating tDCS applied over the rTPJ that is paired with social learning to target processes of social communication and social alignment in autistic adults or adults with high traits of autism.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 20 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
In this arm, participants will undergo 5 sessions of 30 minutes anodal tDCS combined with social learning tasks on consecutive weekdays.
Device: Anodal tDCS + Social Learning
In this arm, participants will undergo 5 sessions of 30 minutes placebo anodal tDCS combined with social learning tasks on consecutive weekdays.
Behavioral: Placebo Anodal tDCS + Social Learning
Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Social 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.
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.
Time frame: Before and after each 5-day block of tDCS stimulation
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.
Time frame: Before and after each 5-day block of tDCS stimulation
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.
Time frame: Before and after each 5-day block of tDCS stimulation
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.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Social Impairment
Social Responsiveness Scale - 2nd Edition (SRS-2) A self-report tool that quantifies social impairment and its severity associated with ASD. Lower SRS-2 scores mean a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Empathy
Empathy Quotient (EQ) A self-report measure that quantifies empathy. Higher EQ scores mean a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Prosodic Alignment
Vocal acoustic analysis measures the rate of prosodic alignment between speakers sharing in a conversation. Higher rates of prosodic alignment between speakers mean a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Emotion Expression Entrainment
Facial expression and gesture analysis measures the rate of emotion entrainment to others during conversation tasks. Increased rate of emotion entrainment means a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Social Learning
Electroencephalography (EEG) spectral power for alpha (8-12Hz) and theta (4-8Hz) oscillations measures changes in social learning. Reductions in power for alpha and theta mean a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Measure of Quality of Life
World Health Organization Quality of Life Questionnaire (WHOQOL) The WHOQOL measures quality of life in areas of social relationships, psychological and physical health, environment, and independence. Higher WHOQOL mean a better outcome.
Time frame: Before and after each 5-day block of tDCS stimulation
Started Mar 2024 (actual). Primary completion is estimated for Oct 2026, 31 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 31 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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