Actively Recruiting

Phase Not Applicable
Age: 5Years - 10Years
All Genders
Healthy Volunteers
ID06227780

FX ENTRAIN: Perturbation of Neurodynamics Underlying Sensory Hyperarousal and Statistical Learning in Youth With Fragile X Syndrome

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-30

180

Participants Needed

1

Research Sites

52 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, leading to differences in brain activity and sensory processing. Researchers are exploring how altered brain rhythms, particularly in alpha and gamma waves, affect cognitive function and sensory sensitivity in individuals with FXS. This research aims to understand these brain activity changes better and test a new approach to improve cognitive function and reduce sensory overload in youth with developmental disorders. The study involves an intervention called Alpha Auditory Entrainment (AAE), which uses special sounds played through headphones to try to normalize brain activity. Participants will be randomly assigned to receive either the AAE stimulus or a sham stimulus (a carrier tone without the entrainment frequencies). The study includes youth aged 5 to 10 years in three groups: those with Fragile X Syndrome, those with Autism Spectrum Disorder, and typically developing controls. The AAE intervention targets brain waves from high theta to high alpha frequencies, aiming specifically for 10 Hz. Participants will be assessed on their brain responses and cognitive performance, including a Word Learning Index during a Statistical Learning Passive Task, measured one week after the intervention. The study uses EEG to monitor brain activity and evaluates sensory and cognitive functions. The trial is randomized and quadruple-masked to ensure unbiased results. Overall involvement includes baseline assessments, the auditory entrainment or sham sessions, and follow-up testing to measure changes in brain activity and learning ability over the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For Fragile X Syndrome cohort: aged 5 to 10 years inclusive
  • Full FMR1 mutation confirmed by genetic testing
  • For Autism Spectrum Disorder cohort: aged 5 to 10 years inclusive
  • No known genetic mutation
  • Documentation of ASD diagnosis
  • Score of 15 or less on SCQ screen
  • Good health as determined by investigator
  • For Typically Developing Controls cohort: aged 5 to 10 years inclusive
  • No known genetic mutation
  • Documentation of ASD diagnosis
  • Score of 15 or less on SCQ screen
  • Good health as determined by investigator
  • Met normal developmental milestones
  • No family history of heritable neuropsychiatric disorders
  • IQ greater than 85 on the Stanford-Binet test
  • Score of 8 or less on SCQ screen
Not Eligible

You will not qualify if you...

  • 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 week

Participants receive either Alpha Auditory Entrainment or a sham stimulus via headphones or speakers to study effects on cognitive function and sensory processing.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45226

Actively Recruiting

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Research Team

J

Jae Citarella

G

Grace Westerkamp

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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