Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called "auditory entrainment" to help improve cognitive abilities and reduce sensory sensitivity in children diagnosed with Fragile X Syndrome (FXS) or Autism Spectrum Disorder (ASD). The researchers believe that children with these conditions process sounds differently and have unique brain activity patterns that can make learning and everyday experiences more challenging. By using special sounds played through headphones, they hope to help normalize brain activity, which could lead to better thinking skills and less sensitivity to sensory input.

To participate in this study, children aged 5 to 10 years who have been diagnosed with FXS or ASD may be eligible if they meet specific criteria, such as having a confirmed genetic mutation for FXS or no known genetic mutations for ASD. It’s important that potential participants are generally healthy and do not have significant hearing or vision problems. During the trial, children will listen to the targeted sounds, and researchers will monitor their progress to see how well this treatment works. This study is currently recruiting participants, and it aims to offer new hope for improving the quality of life for children with these developmental disorders.

Gender

ALL

Eligibility criteria

• 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 that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months