NCT05957549 · Children's Hospital Medical Center, Cincinnati
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age
What this study is about
Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds.
View original scientific description
Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. The underlying brain activity for sound perception and speech learning in Fragile X is not well understood, especially in the infant, toddler, and preschool years. This study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with Fragile X Syndrome.
Interventions
OTHER
Speech discrimination
Two different speech sounds are played at the same sound intensity.
Primary outcome measures
Change in Mullen Scales of Early Learning
Time frame: at single study visit between ages of 2-4 years inclusive
change in Mullen Scales scores (age-corrected) from baseline on all subscales, including Expressive Language, Receptive Language, FIne Motor, Gross Motor, and Visual Reception. T-Scores from the Mullen Scales of Early Learning (MSEL) have a mean of 50 and a standard deviation of 10. Range=20-80. Higher scores indicate more advanced developmental skills.
Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brain
Time frame: at single study visit between ages of 2-4 years inclusive
Relative increase in oxygenated versus deoxygenated hemoglobin for no sounds, low intensity sounds, and medium intensity sounds. Measured via functional Near Infrared Spectroscopy with optodes placed over frontal, temporal, and parietal language regions.
Changes in amplitude of mismatch negativity response during sound discrimination
Time frame: at single study visit between ages of 2-4 years inclusive
Electroencephalography is measured over the scalp while participant listens to speech sounds with infrequent "oddball" stimuli. Amplitude of the P100 for all stimuli as well as amplitude of the mismatch negativity response (frequent minus infrequent response) as well as change in these metrics over development are tracked in all groups.
Changes in hearing thresholds
Time frame: at single study visit between ages of 2-4 years inclusive
Hearing thresholds in dB as assessed using Conditioned Play Audiometry (CPA) or Visual Reinforced Audiometry (VRA) dependent on child age and developmental ability.
Otoacoustic Emissions (OAEs)
Time frame: at single study visit between ages of 2-4 years inclusive
Signals produced by excitation of hair cells in cochlea are measured for a range of frequencies.
Changes in tympanometric pressure profile in the inner ear
Time frame: at single study visit between ages of 2-4 years inclusive
Wide Band Tympanometry is completed to measure variability in tympanometric pressure for left and right ears that may affect hearing profile.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
- able to sit independently
- English is spoken at home
Exclusion criteria
- For all participants: no seizures in the past 6 months
- For typical development group and Fragile X group: not born prior to 32 weeks gestation
Where
- Cincinnati, Ohio
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Jul 10, 2025 · Source of record for eligibility and locations