Alpha Auditory Entrainment for Fragile X Syndrome
(ENTRAIN Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Alpha Auditory Entrainment for Fragile X Syndrome?
Research shows that individuals with Fragile X Syndrome have altered brain activity, including changes in alpha and gamma oscillations, which are linked to sensory hypersensitivity and intellectual disability. Alpha Auditory Entrainment may help by targeting these brain wave patterns, potentially improving sensory processing and reducing hyper-excitability.12345
How is Alpha Auditory Entrainment treatment different from other treatments for Fragile X Syndrome?
Alpha Auditory Entrainment is unique because it targets the brain's alpha waves, which are often disrupted in Fragile X Syndrome, to help manage symptoms like sensory hypersensitivity and intellectual disability. This approach focuses on modulating brain activity through sound, rather than using medication, making it a novel non-drug therapy for this condition.23456
What is the purpose of this trial?
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.
Research Team
Ernest V Pedapati, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Eligibility Criteria
This trial is for young individuals with developmental disorders such as Autism Spectrum Disorder, Asperger Syndrome, and Fragile X Syndrome. It's designed to help those who have cognitive challenges and are overly sensitive to sensory input.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo alpha auditory entrainment to normalize brain activity and improve cognitive function and sensory hypersensitivity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Alpha Auditory Entrainment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator