Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth
Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have
| Condition(s) | Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioni |
| Who can participate | Inclusion Criteria: * FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing. * ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator. * TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen. Exclusion Criteria: * All subjects: 1) Patient has auditory or visual impairments |
| Ages | 5 Years to 10 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Locations | Cincinnati, Ohio, United States |
| Start date | 2023-05-24 |
| NCT ID | NCT06227780 |
| Official listing | https://clinicaltrials.gov/study/NCT06227780 |