Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders (NCT06227780)
FX ENTRAIN: Perturbation of Neurodynamics Underlying Sensory Hyperarousal and Statistical Learning in Youth With FXS
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
Age range: 5 Years to 10 Years
🧪 Interventions in This Study
- Alpha Auditory Entrainment (OTHER)
- Sham (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
📞 Contact the Study Coordinator
Phone: (513) 636-0875
Email: Jae.Citarella@cchmc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fragile X Syndrome
- Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge — Cincinnati, Ohio
- An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome — Irvine, California
- Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS — Phoenix, Arizona
- Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant — Cincinnati, Ohio
- Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome — Sherbrooke, Quebec
- Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) — Phoenix, Arizona
Explore by condition: All Fragile X Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.