ClinicalTrials.gov record NCT06560242
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study records brain activity while infants and toddlers listen to speech, stories, and nonspeech sounds to study early sound perception. It compares infants with Fragile X Syndrome to control infants and follows changes over time. Visits may occur around 6, 12, 18, and 24 months of age to track development.
What it is studying. The study is trying to measure and localize how infants with Fragile X process sounds and speech. Investigators use simultaneous electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) while presenting speech, stories, and nonspeech sounds to quantify auditory hypersensitivity and neural differences, and relate those measures to developmental and hearing assessments.
What the researchers hope to learn. To identify early brain markers of auditory hypersensitivity in Fragile X Syndrome; to describe how neural responses to speech and sounds develop in infancy; to relate brain measures to hearing tests and early language development.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Speech discrimination
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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 EEG/fNIRS 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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Children attend one or more study visits (possible at 6, 12, 18, and 24 months). Visits include developmental testing (Mullen Scales), parent questionnaires, and hearing assessments. While the child listens to speech, stories, and nonspeech sounds, investigators record brain activity using simultaneous EEG and functional near‑infrared spectroscopy (fNIRS); home language is recorded with the LENA system. Tests also include otoacoustic emissions and wide-band tympanometry; hearing thresholds are measured with conditioned play audiometry or visual reinforced audiometry depending on the child's age and ability.
How the study is structured. Interventional single-group study in which participating infants listen to sounds while researchers record brain electrical activity (EEG) and blood-oxygen changes in the brain (fNIRS). There is no masking; the same procedures are applied to all participants. Children may have repeated study visits at several ages (possible visits at 6, 12, 18, and 24 months) to observe changes over time.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on fragile X syndrome
Important dates
- Study start
- Oct 31, 2022
- Primary completion
- Mar 1, 2027 (estimated)
- Study completion
- Mar 1, 2027 (estimated)
- Target enrollment
- 30 participants (estimated)
- Last updated on registry
- Jul 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Principal investigator
- Elizabeth Smith, Assistant Professor of Pediatrics
Children's Hospital Medical Center, Cincinnati
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Elizabeth Smith, PhD 📞 5135171383 ✉ elizabeth.smith3@cchmc.org
- Craig Erickson, MD 📞 5136366553 ✉ craig.erickson@cchmc.org
Participating sites (1)
- Cincinnati Children's HospitalRecruiting
Cincinnati, Ohio, 45229 · United States
- Elizabeth Smith, PhD · 5135171383 · elizabeth.smith3@cchmc.org
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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