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

Children's Hospital Medical Center, Cincinnati · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06227780

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–10 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
180
US sites recruiting
1
Study start
May 24, 2023
Record last updated
March 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Alpha Auditory Entrainment; Sham

Conditions: Fragile X Syndrome; Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45226

    Site contact: Jae Citarella · 513-636-0875 · Jae.Citarella@cchmc.org

Study contacts (from the official record)

  • Jae Citarella · 513-636-0875 · Jae.Citarella@cchmc.org
  • Grace Westerkamp · 513-636-2332 · grace.westerkamp@cchmc.org
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Alpha Auditory Entrainment for Cognitive Enhancement and Sensory… (NCT06227780) | Bored Studies