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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06227780
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 10 Years
Healthy Volunteers
Accepted

Interventions

  • Alpha Auditory Entrainment — OTHER
    Alpha Brainwave Entrainment (AAE) stimulus: starts at high theta range (7-Hz) through high alpha (13-Hz) in 2 Hz steps on a 500 Hz sine carrier tone Target frequency: 10 Hz Delivery: headphones/speakers
  • Sham — OTHER
    Sham stimulus: carrier tone alone Target frequency: N/A Delivery: headphones/speakers

Study Details

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.

Key Dates

Start date
May 24, 2023
Status verified
Mar 2026
Primary completion
May 24, 2027
Completion
May 24, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Fragile X Syndrome
    Fragile X Syndrome with full FMR1 mutations (\>200 CGG repeats; at least partial FMR1 gene methylation)
  • Active Comparator: Autism Spectrum Disorder Controls
    Age and sex-matched with FXS cohort
  • Active Comparator: Typically Developing Controls
    Subjects with neither disorder who have met normal developmental milestones

Primary Outcome Measure

Alpha auditory entrainment versus sham effect on Word Learning Index during the Statistical Learning Passive Task. [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45226
Jae Citarella
[email protected]
513-636-0875
Grace Westerkamp
[email protected]
Ernest V Pedapati, MD (PRINCIPAL_INVESTIGATOR)
Craig Erickson, MD (SUB_INVESTIGATOR)
Elizabeth Smith, PhD (SUB_INVESTIGATOR)
Steve Wu, MD (SUB_INVESTIGATOR)
Meredith Will, PhD (SUB_INVESTIGATOR)
Rebecca Shaffer, PhD (SUB_INVESTIGATOR)
Makoto Miyakoshi, PhD (SUB_INVESTIGATOR)
Lauren Schmitt, PhD (SUB_INVESTIGATOR)
Kelli Dominick, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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