Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560242
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRSEEG- Infant
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRSEEG- Infant
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Fragile X Syndrome FXS is the leading monogenic cause of intellectual disability and autism and is associated with extremely high risk for early delays in speech and language While infancy is essential for speech and language development neural mechanisms for language impairments have been studied entirely in older children and adults with FXS Therefore markers for speech and language impairments are unavailable in infants and toddlers with FXS to predict severity test potential mechanisms and track response to intervention The investigators have identified a hallmark brain-based phenotype of hyperresponsiveness to sounds in adolescents and adults with FXS This fundamental alteration in cortical responses to sound could influence early language delays but this phenotype has not been explored in infants or toddlers with FXS
Specifically in this study the investigators will use simultaneous EEGfNIRS during presentation of simple speech stories and nonspeech sounds to quantify and localize auditory hypersensitivity and neural differentiation in 30 infants and toddlers including 15 with FXS and 15 controls Infants will complete visits at different ages with possible visits at 6 months 12 months 18 months and 24 months so that changes with development can be tracked over time
Specifically in this study the investigators will use simultaneous EEGfNIRS during presentation of simple speech stories and nonspeech sounds to quantify and localize auditory hypersensitivity and neural differentiation in 30 infants and toddlers including 15 with FXS and 15 controls Infants will complete visits at different ages with possible visits at 6 months 12 months 18 months and 24 months so that changes with development can be tracked over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None