Cortica Clinical Outcomes Studies
Evaluating the Effectiveness of a Comprehensive, Personalized, Medically Based Care Model on Adaptive Behavior Outcomes in Autism
Link to Preprint: 10.31234/osf.io/56px3
An Observational Study of Cranial Electrotherapy Stimulation (CES) on Behavioral Regulation in a Mixed Clinical Cohort
Link to preprint: https://psyarxiv.com/q5z4t/
An Open-Label Study of Cranial Electrotherapy Stimulation (CES) on Sleep, Constipation, and Headaches in a Neurodivergent Cohort
Link to Abstract:
Submitted to Child Neurology Society 2023
Objective:
Children with neurodevelopmental differences (NDD) often experience comorbid health-related issues such as insomnia, headaches, and constipation. Cranial electrotherapy stimulation (CES) is a non-invasive transcranial current stimulation technique that has shown efficacy in adult populations for headaches and insomnia. This study examined the effects of a 4-week CES intervention on comorbid health concerns in a cohort of children and adolescents with a variety of neurodevelopmental diagnoses including autism, attention-deficit hyperactivity disorder, and sensory processing disorder.
Methods:
A single-arm observational study recruited 263 individuals aged 4-24 receiving care at our clinical centers. Participants were instructed to administer CES treatment at home using an AlphaStim AID device for 20 minutes per day, at least 5 days a week. Parent-reported assessments of sleep, headaches, and constipation were completed before and after the intervention. Multilevel logistic regression models evaluated within-person change in symptoms pre- and post-intervention.
Results:
At baseline, 70% of children reported problems with sleep, 15% with headaches, and 38% with constipation. After 4 weeks of CES treatment, the study population showed significant improvements in sleep (17% reduction) and constipation (20% reduction), but not headaches (1% reduction).
Conclusion: This study highlights the use of cranial electrotherapy stimulation in the context of clinical care for alleviating symptoms of sleep disruption and constipation in individuals with NDDs. These findings support the need for future randomized controlled trials to assess the efficacy of CES in neurodivergent children and adolescents with comorbid health concerns.
Pharmacogenetic moderation of longitudinal change in adaptive behavior over the course of clinical care in a pediatric autism cohort
Link to Abstract:
Presented at International Society for Autism Research 2023
Background
Children with autism demonstrate a range of neurodevelopmental differences including challenges with adaptive functioning. The assessment of adaptive functioning is a routine clinical practice to measure progress and response to treatments over time. However, research suggests that certain single nucleotide polymorphisms (SNPs) may moderate children’s response to environmental influence, and thus, may impact change in adaptive behavior outcomes over time. Specifically, the short (S) allele of the promoter region of SLC6A4, encoding the serotonin transporter protein, has been associated with increased susceptibility to cognitive and behavioral stress. Similarly, brain-derived neurotrophic factor (BDNF) SNP is involved in neuronal plasticity the pathogenesis of autism.
Objectives
This study first examined longitudinal adaptive behavior outcomes in children with autism currently receiving clinical care. The second aim of this study was to evaluate differential change in adaptive behaviors based on pharmacogenetic polymorphisms, specifically SLC6A and BDNF Val66Met.
Methods
Children with an ASD diagnosis (N=157) and pharmacogenetic testing were evaluated with the Vineland Adaptive Behavior Scales up 7 times between the ages of 20-90 months. We constructed multilevel models to characterize growth curves within each adaptive behavior domain (composite score, communication, socialization, and daily living skills). We included a Time X SLC6A4 and Time X BDNF Val66Met interaction term (in separate models) to compare relative rates of growth based on genetic background.
Results
Multilevel models showed a main effect of time, such that adaptive behaviors demonstrated improvement over course of treatment for both cohorts in all domains (p≤.02). There was a significant SLC6A4 X Time interaction for the communication (p=.04) and daily living skills (p=.03) sub-scores but not the adaptive behavior composite score or socialization score. The significant interaction showed that dosage of the S allele predicted slower or null rates of improvement in adaptive behaviors over time. Further, results showed a significant BDNF Val66Met X Time interaction on the adaptive behavior composite score (p=.005), socialization (p=.0001), and daily living skills (p=.02), but not communication. The interaction demonstrated a faster rate of growth in adaptive behaviors for Val homozygous individuals compared to Met homozygous or Mat/Val heterozygous genotypes.
Conclusions
Results indicate that children with autism show differential rates of change in adaptive behaviors over the course of clinical care based upon genetic background. Dosage of the S allele of SLC6A4 predicted poorer rates of change in adaptive behaviors. This may indicate that susceptibility to environmental stress modulates developmental trajectories in children with autism. Similarly, Val homozygous genotypes in BDNF Val66Met were predictive of greater rates of improvement in adaptive behaviors relative to Met allele genotypes. Results demonstrate the importance and utility of genetic screening in clinical care to guide individualized treatment plans.
Effects of COVID-19 Pandemic on Adaptive Behaviors: Evaluating the Role of In-Person vs. Tele-Health Care
Link to Abstract:
Submitted to Child Neurology Society 2023
Objective:
The COVID-19 pandemic resulted in unprecedented disruptions in the availability of therapy services for autistic children. To maintain continuity of care, many providers of Applied Behavioral Analysis (ABA) and other therapies shifted from in-person to telehealth settings. In the current study, we retrospectively analyzed measures of adaptive function in autistic children between 2019 and 2022 to understand the effects of pandemic-related shifts in therapy modality on functional outcomes.
Methods:
Our study compared cohorts of children (matched on age and sex) who received ABA therapy at our clinical centers and completed initial Vineland-3 assessments before the pandemic (N=275) and after pandemic shutdowns ended (N=275). Growth curve multilevel linear models assessed the interactive effects of age, era (Pre-COVID or Peri-COVID), and assessment-wave on adaptive behaviors.
Results:
We found that baseline adaptive behaviors varied as a function of age in the pre- and peri-COVID groups. Older children in the pre-COVID group had lower communication, socialization, and composite ABC scores than older children in the peri-COVID group. Younger children in the pre-COVID group did not differ from their post-COVID counterparts. However, longitudinal models revealed similar rates of improvement in both groups.
Conclusions:
Our results suggest that children who were able to participate in ABA therapy during the period of COVID-related lockdowns had similar improvement in adaptive behavior outcomes compared to a matched cohort who received therapy before the pandemic. In other words, children who were able to participate in therapies during the pandemic showed benefit regardless of therapy modality. Baseline characteristics of older children in these groups differed somewhat, suggesting that older children with more severe impairments may have had less access to therapy during the pandemic period.
NIH-Funded Sensory Processing, Imaging, and Neurodevelopment (SPIN) Study
Brief Report: Characterization of Sensory Over-Responsivity in a Broad Neurodevelopmental Concern Cohort Using the Sensory Processing Three Dimensions (SP3D) Assessment
Link to Manuscript: 10.1007/s10803-022-05747-0
Sensory Over-Responsivity (SOR) is an increasingly recognized challenge among children with neurodevelopmental concerns (NDC). To investigate, we characterized the incidence of auditory and tactile over-responsivity (AOR, TOR) among 82 children with NDC. We found that 70% of caregivers reported concern for their child's sensory reactions. Direct assessment further revealed that 54% of the NDC population expressed AOR, TOR, or both - which persisted regardless of autism spectrum disorder (ASD) diagnosis. These findings support the high prevalence of SOR as well as its lack of specificity to ASD. Additionally, AOR is revealed to be over twice as prevalent as TOR. These conclusions present several avenues for further exploration, including deeper analysis of the neural mechanisms and genetic contributors to sensory processing challenges.
Characterizing Sensory Processing Typologies in a Mixed Neurodevelopmental Cohort: Evaluating Associations with Emotion Dysregulation, Anxiety, and ADHD
Link to Abstract:
Submitted to Child Neurology Society 2023
Objective:
Children with autism and sensory processing disorder (SPD) demonstrate distinct patterns of sensory processing abilities and frequently show problems with internalizing and externalizing behaviors. Further research is needed to 1) characterize the prevalence of emotional dysregulation in children with SPD and autism, 2) develop data-driven sub-typologies of sensory processing profiles, 3) evaluate differences in emotion dysregulation, anxiety, and ADHD based on sensory typology.
Methods:
The current study included children (ages 8-12) with a confirmed diagnosis of autism and/or SPD. Parent-reported sensory over-responsivity, under-responsivity, and seeking behaviors were collected using the Sensory Processing Scales-Inventory. Additionally, parent-reported emotional dysregulation and anxiety measures were obtained using the BASC-3, and ADHD-scores were collected from the Connors-3.
Results:
Results showed an increased prevalence of clinically concerning emotion dysregulation problems (40%) Five sensory profiles were identified using latent profile analysis: Typical Processing, Sensory Seeking (SS), Sensory Under-responsive (SUR), Sensory Over-Responsive (SOR), and Combined. The SOR, SS, and Combined subgroups exhibited higher emotion dysregulation scores than the other groups. The SOR and Combined groups had higher anxiety scores than the other groups, and the SS and Combined groups demonstrated higher ADHD scores.
Conclusions:
This study suggests a higher prevalence of emotional dysregulation among children with autism and SPD. Children with SOR and SS subtypes were uniquely associated with elevated anxiety and ADHD symptoms, respectively, but shared problems with emotion dysregulation in common. These findings suggest that emotion dysregulation may be a shared neurocognitive deficit underlying internalizing and externalizing symptoms in children with neurodevelopmental differences.