Recruiting

Alpha Auditory Entrainment

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06227780

Conditions

Fragile X Syndrome

Autism Spectrum Disorder

Autistic Disorder

Asperger Syndrome

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Accepted

Interventions

Alpha Auditory Entrainment

Sham

Study Details

Brief 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 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

Fragile X Syndrome

Autism Spectrum Disorder

Autistic Disorder

Asperger Syndrome

Study ID

NCT06227780

Start date

May 24, 2023

Status verified date

Mar, 2026

Completion date

May 24, 2028

Anticipated

Primary completion date

May 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Alpha Auditory Entrainment

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

Sham stimulus: carrier tone alone

Target frequency: N/A

Delivery: headphones/speakers

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 and Locations

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45226

Contacts

Principal Investigator:

Ernest V Pedapati, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Neurodevelopmental Disorders
  • Autistic Disorder
  • Autism Spectrum Disorder
  • Fragile X Syndrome
  • Fragile X
  • FXS
  • ASD
  • Asperger
  • Autism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-30.