Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495684
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-25
Brief Title:
Effects of Multiple-Session tDCS on Behavioral Physiological and Electrophysiological Measures With Autistic Adults
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Effects of Multiple-Session Transcranial Direct Current Stimulation tDCS on Behavioral Physiological and Electrophysiological Measures With Adults With Autism Spectrum Disorder ASD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 gesturesIt 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 rTPJs role in social alignment because of the rTPJs 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
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 andor 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 gesturesIt 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 rTPJs role in social alignment because of the rTPJs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P20GM109089 | NIH | None | None |