Using sound to improve cognitive function and sensory sensitivity in youth with developmental disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A program to improve social skills in adults with autism

  This study is trying out a new program called TUNE In to see if it can help adults with autism improve their social skills and feel more comfortable in everyday situations.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT06859918

• Prednisone in adults with an immune-related subtype of autism

  This study tests whether prednisone, an anti-inflammatory drug, can help adults with a specific immune-related form of autism compared to a placebo.

  Recruiting Early Phase 1 Massachusetts General Hospital · Lexington, Massachusetts · NCT06934915

• Inclusive physical activity program for adults with intellectual disabilities

  This study is testing a new fitness program for adults with intellectual disabilities to see if it helps them be more active and feel better over 16 weeks.

  Recruiting University of North Carolina, Chapel Hill · Fayetteville, Arkansas and 1 other locations · NCT06740162

• Improving transition outcomes for students with autism

  This study is testing a new program to help autistic students set and achieve their goals as they transition from high school to adulthood, with support for them and their families.

  Recruiting Ball State University · Muncie, Indiana · NCT06309160

• Supplementation therapy for anxiety and depression in autistic individuals

  This study is testing if a supplement called PEA can help reduce anxiety and depression in young adults with Level 1 Autism Spectrum Disorder who haven't found relief with other treatments.

  Recruiting University of Udine · Udine, UD · NCT06187090

• Comparing Sertraline and Placebo for Treating Anxiety in Children with Neurodevelopmental Disorders

  This study is testing if the medication sertraline can help reduce anxiety in children and teens aged 8-17 with neurodevelopmental disorders like autism and Fragile X syndrome compared to a placebo.

  Recruiting at 6 sites Phase 2 Holland Bloorview Kids Rehabilitation Hospital · Calgary, Alberta and 6 other locations · NCT06081348

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.