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Behavioural Intervention

Speech Discrimination for Fragile X Syndrome

N/A
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to sit independently
Be younger than 18 years old
Must not have
No seizures in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 month, 12 month, 18 month, and 24 month visits
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how children with Fragile X Syndrome process speech and sounds differently. The study will use behavioral assessments, brain imaging, and hearing tests to investigate the differences in speech and language abilities

Who is the study for?
This trial is for infants with Fragile X Syndrome, a genetic condition that affects language and sound perception. It aims to understand how these children differ in speech understanding and hearing from an early age.
What is being tested?
The study tests how babies with Fragile X Syndrome discriminate between different sounds. It involves behavioral assessments, brain imaging (fNIRS/EEG), and hearing tests to track the development of their speech and auditory processing.
What are the potential side effects?
Since this trial focuses on non-invasive testing methods like neuroimaging and behavioral assessments, there are minimal side effects expected. The main concerns may relate to discomfort or anxiety during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can sit up on my own without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had a seizure in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 month, 12 month, 18 month, and 24 month visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 month, 12 month, 18 month, and 24 month visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mullen Scales of Early Learning
Changes in LENA vocalizations and conversational turns
Changes in amplitude of mismatch negativity response during sound discrimination
+4 more
Secondary study objectives
Sensory Profile 2 Attentional subtest
Sensory profile 2 Auditory Processing subtest

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Speech SoundsExperimental Treatment1 Intervention
Participants listen to speech sounds while the investigators measure electrical and hemodynamic changes in the brain.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,307 Total Patients Enrolled
7 Trials studying Fragile X Syndrome
465 Patients Enrolled for Fragile X Syndrome
~14 spots leftby Aug 2026
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