RecruitingNot Applicable

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

United States90 participantsStarted 2022-10-04

Plain-language 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, 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.

Who can participate

Age range

24 Months – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Mullen Scales of Early Learning

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brain

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in amplitude of mismatch negativity response during sound discrimination

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in hearing thresholds

Timeframe: at single study visit between ages of 2-4 years inclusive

Otoacoustic Emissions (OAEs)

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in tympanometric pressure profile in the inner ear

Timeframe: at single study visit between ages of 2-4 years inclusive

Trial details

NCT IDNCT05957549

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Elizabeth Smith, PhD

5135171383 elizabeth.smith3@cchmc.org

View on ClinicalTrials.gov More Fragile X Syndrome trials

Plain-language summary

Who can participate

Age range

24 Months – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Mullen Scales of Early Learning

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in oxygenated and deoxygenated hemoglobin concentration in response to sounds in language regions of the brain

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in amplitude of mismatch negativity response during sound discrimination

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in hearing thresholds

Timeframe: at single study visit between ages of 2-4 years inclusive

Otoacoustic Emissions (OAEs)

Timeframe: at single study visit between ages of 2-4 years inclusive

Changes in tympanometric pressure profile in the inner ear

Timeframe: at single study visit between ages of 2-4 years inclusive