Actively Recruiting
Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-30
180
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.
CONDITIONS
Official Title
Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is aged between 5 and 10 years inclusive
- For Fragile X Syndrome group: confirmed full FMR1 mutation by genetic testing
- For Autism Spectrum Disorder group: no known genetic mutation
- For Autism Spectrum Disorder group: documented diagnosis of ASD
- For Autism Spectrum Disorder group: score less than or equal to 15 on SCQ screen
- For Autism Spectrum Disorder group: good health as assessed by investigator
- For Typically Developing Control group: no known genetic mutation
- For Typically Developing Control group: documentation of ASD diagnosis
- For Typically Developing Control group: score less than or equal to 15 on SCQ screen
- For Typically Developing Control group: good health as assessed by investigator
- For Typically Developing Control group: normal developmental milestones
- For Typically Developing Control group: no family history of heritable neuropsychiatric disorders
- For Typically Developing Control group: IQ greater than 85 on Stanford-Binet test
- For Typically Developing Control group: score less than or equal to 8 on SCQ screen
You will not qualify if you...
- Participant has auditory or visual impairments that cannot be corrected
- History of substance abuse or dependence within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45226
Actively Recruiting
Research Team
J
Jae Citarella
CONTACT
G
Grace Westerkamp
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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