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

NCT06495684 | Recruiting DMC FDA Device

• 2 other identifiers: 24-059P20GM109089
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Autism or Autistic Traits

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Anodal tDCS + Social Learning

EXPERIMENTAL

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

Placebo anodal tDCS + Social Learning

SHAM COMPARATOR

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

Interventions

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.

Placebo anodal tDCS + Social Learning

Anodal tDCS + Social Learning DEVICE

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

Anodal tDCS + Social Learning

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Bill Shuttleworth, Ph.D.

  University of New Mexico

  STUDY DIRECTOR

Central Study Contacts

Joan Esse Wilson, Ph.D.

CONTACT

575-646-4313; joanwilson@unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will receive 5 sessions of active tDCS in one block and 5 sessions of sham tDCS in another block. The tDCS device allows for researchers and participants to remain blind to the condition until the end of the study by randomly assigning participants to either the active or the sham block and providing the study team members a unique code to enter into the tDCS device at the start of each session.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject, cross-over, double-blind, randomized controlled trial

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 11, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)