Effects of Multiple-Session tDCS on Behavioral, Physiological, and Electrophysiological Measures With Autistic Adults
NCT Number: NCT06495684
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Autism or Autistic Traits
Interventions: DEVICE: Anodal tDCS + Social Learning|BEHAVIORAL: Placebo Anodal tDCS + Social Learning
Sponsor: University of New Mexico
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-31

Summary:
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.

Primary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., Before and after each 5-day block of tDCS stimulation