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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of New Mexico

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Anodal tDCS + Social LearningExperimental treatment 1 intervention
Group B: Placebo anodal tDCS + Social LearningSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

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