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NCT Number: NCT06495684

Effects of Multiple-Session Transcranial Direct Current Stimulation (tDCS) on Behavioral, Physiological, and Electrophysiological Measures With Adults With Autism Spectrum Disorder (ASD)

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.

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Key information

Conditions

Autism Spectrum Disorder Autism or Autistic Traits Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location status: Recruiting

Location contact

Davin Quinn

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Right-handed based on the Edinburgh Handedness Inventory
  • Score of >= 85 on Shipley-2

Exclusion criteria

  • 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)
  • No hospitalization for depression, anxiety, or substance abuse in the past 12 months
  • No individuals who are currently pregnant
  • No pacemakers
  • No history of neurological disorders such as stroke, multiple sclerosis, bipolar disorder, encephalitis, epilepsy, seizure disorder, or amyotrophic lateral sclerosis

Treatment and study plan

Anodal tDCS + Social Learning

Device

Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.

Placebo Anodal tDCS + Social Learning

Behavioral

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.

Primary outcomes

  1. Measure of Emotional Distress - Anxiety

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  2. Measure of Social Anxiety

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  3. Measure of Social Anxiety/Anxiety

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  4. Measure of Social Anxiety

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  5. Measure of Social Impairment

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  6. Measure of Empathy

    Time frame: Before and after each 5-day block of tDCS stimulation

    Empathy Quotient (EQ) A self-report measure that quantifies empathy. Higher EQ scores mean a better outcome.

  7. Measure of Prosodic Alignment

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  8. Measure of Emotion Expression Entrainment

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  9. Measure of Social Learning

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

  10. Measure of Quality of Life

    Time frame: Before and after each 5-day block of tDCS stimulation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Esse Wilson, Ph.D.

CONTACT

[email protected]

575-646-4313

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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