Autism Spectrum DisorderNCT06495684
Effects of Multiple-Session Transcranial Direct Current Stimulation (tDCS) on Behavioral, Physiological, and Electrophysiological Measures With Adults With Autism Spectrum Disorder (ASD)
A study testing Anodal tDCS + Social Learning in people with Autism Spectrum Disorder and Autism or Autistic Traits, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism or Autistic Traits
- What is being tested?
- Anodal tDCS + Social Learning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Davin Quinn, DQuinn@salud.unm.edu
About this study
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Anodal tDCS + Social Learning, Placebo Anodal tDCS + Social Learning
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCS + Social LearningDevice
Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Placebo Anodal tDCS + Social LearningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo Anodal tDCS + Social Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after each 5-day block of tDCS stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Mar 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, cross-over, double-blind, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Bill Shuttleworth, Ph.D., Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495684
- Sponsor's protocol ID
- 24-059
- Other IDs
- P20GM109089
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multiple-Session Transcranial Direct Current Stimulation (tDCS) on Behavioral, Physiological, and Electrophysiological Measures With Adults With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT06495684
- Acronym / sponsor ID
- 24-059
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Within-subject, cross-over, double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + Social Learning | Experimental | Device: Anodal tDCS + Social LearningIn this arm, participants will undergo 5 sessions of 30 minutes anodal tDCS combined with social learning tasks on consecutive weekdays. |
| Placebo anodal tDCS + Social Learning | Sham comparator | Behavioral: Placebo Anodal tDCS + Social LearningIn this arm, participants will undergo 5 sessions of 30 minutes placebo anodal tDCS combined with social learning tasks on consecutive weekdays. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS + Social LearningAnodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli. | Device | Anodal tDCS + Social Learning |
| Placebo Anodal tDCS + Social LearningSocial 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. | Behavioural | Placebo anodal tDCS + Social Learning |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bill Shuttleworth, Ph.D. study director
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS + Social Learning in people with Autism Spectrum Disorder and Autism or Autistic Traits, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Esse Wilson, Ph.D. (575-646-4313, joanwilson@unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Emotional Distress - Anxiety (time frame: Before and after each 5-day block of tDCS stimulation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.