Using sound to improve cognitive function and sensory sensitivity in youth with developmental disorders
FX ENTRAIN: Perturbation of Neurodynamics Underlying Sensory Hyperarousal and Statistical Learning in Youth With FXS
NA · Children's Hospital Medical Center, Cincinnati · NCT06227780
This study is testing if listening to special sounds can help improve thinking skills and reduce sensitivity to noise in children with Fragile X Syndrome and Autism Spectrum Disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 5 Years to 10 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06227780 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of alpha auditory entrainment on cognitive enhancement and sensory hypersensitivity in children aged 5-10 with Fragile X Syndrome and Autism Spectrum Disorder. The researchers hypothesize that auditory entrainment can normalize brain activity patterns that are altered in these conditions, potentially improving cognitive functioning and reducing sensory sensitivity. The study will involve measuring brain activity through EEG while participants listen to specially designed sounds. The approach aims to address the underlying neurodynamics that contribute to cognitive and sensory challenges in these youth.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-10 years with a confirmed diagnosis of Fragile X Syndrome or Autism Spectrum Disorder.
Not a fit: Patients with auditory or visual impairments that cannot be corrected may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved cognitive abilities and reduced sensory sensitivities in children with developmental disorders.
How similar studies have performed: While there have been studies exploring auditory entrainment, this specific approach targeting neurodevelopmental disorders is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Ernest V Pedapati, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jae Citarella
- Email: Jae.Citarella@cchmc.org
- Phone: 513-636-0875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Neurodevelopmental Disorders, Fragile X, FXS, ASD