Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06560242
Status
Recruiting
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Conditions

  • Fragile X Syndrome

Eligibility Criteria

Sex
ALL
Age
6 Months - 26 Months
Healthy Volunteers
Accepted

Interventions

  • Speech discrimination — OTHER
    Two different speech sounds are played at the same sound intensity.

Study Details

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 and toddler 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.

Key Dates

Start date
Oct 31, 2022
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Speech Sounds
    Participants listen to speech sounds while the investigators measure electrical and hemodynamic changes in the brain.

Primary Outcome Measure

Change in Mullen Scales of Early Learning [ Time Frame: at 12 month, 18 month, and 24 month visits ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's HospitalCincinnatiOhio45229
Elizabeth Smith, PhD
[email protected]
5135171383

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By research site
Cincinnati Children's Hospital· Cincinnati, OH

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