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Behavioural Intervention

Alpha Auditory Entrainment for Fragile X Syndrome (ENTRAIN Trial)

N/A
Recruiting
Led By Ernest V Pedapati, MD
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
FXS Cohort: Aged 5-15 years, inclusive; Patient has full FMR1 mutation confirmed by genetic testing.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a condition called Fragile X Syndrome (FXS), which is a complex disorder that affects brain development. The researchers have studied this condition in both humans and animals, but so

Who is the study for?
This trial is for young individuals with developmental disorders such as Autism Spectrum Disorder, Asperger Syndrome, and Fragile X Syndrome. It's designed to help those who have cognitive challenges and are overly sensitive to sensory input.
What is being tested?
The study tests Alpha Auditory Entrainment—a technique using special sounds played through headphones—to see if it can improve brain activity, cognition, and reduce sensory hypersensitivity in participants with these conditions.
What are the potential side effects?
Since the intervention involves auditory stimulation, potential side effects may include discomfort from wearing headphones or sensitivity to sound. However, no significant adverse effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 5 and 15 years old with a confirmed full FMR1 mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alpha auditory entrainment versus sham effect on Word Learning Index during the Statistical Learning Passive Task.
Other study objectives
Alpha auditory entrainment versus sham effect on the Behavior Learning Effect during the Statistical Learning Active Task.

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Fragile X SyndromeExperimental Treatment2 Interventions
Fragile X Syndrome with full FMR1 mutations (\>200 CGG repeats; at least partial FMR1 gene methylation)
Group II: Autism Spectrum Disorder ControlsActive Control2 Interventions
Age and sex-matched with FXS cohort
Group III: Typically Developing ControlsActive Control2 Interventions
Subjects with neither disorder who have met normal developmental milestones

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
837 Previous Clinical Trials
6,565,163 Total Patients Enrolled
1 Trials studying Asperger Syndrome
142 Patients Enrolled for Asperger Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,056 Previous Clinical Trials
2,737,964 Total Patients Enrolled
3 Trials studying Asperger Syndrome
5,077 Patients Enrolled for Asperger Syndrome
Ernest V Pedapati, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
~109 spots leftby May 2027
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