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Behavioural Intervention

Fragile X Syndrome for Autism Spectrum Disorder (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

ENTRAIN Trial 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.Check my eligibility

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.See study design

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.

ENTRAIN Trial 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.

ENTRAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alpha auditory entrainment versus sham effect on Word Learning Index during the Statistical Learning Passive Task.

Other outcome measures

Alpha auditory entrainment versus sham effect on the Behavior Learning Effect during the Statistical Learning Active Task.

ENTRAIN 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,411 Total Patients Enrolled

23 Trials studying Autism Spectrum Disorder

10,354 Patients Enrolled for Autism Spectrum Disorder

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,617 Total Patients Enrolled

34 Trials studying Autism Spectrum Disorder

9,544 Patients Enrolled for Autism Spectrum Disorder

Ernest V Pedapati, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 25 eligible to participate in this recruitment for the clinical trial?

"In order to be eligible for participation in this trial, individuals must meet the age criteria of being at least 5 years old and no older than 15."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"As per the information provided on clinicaltrials.gov, this study is currently actively seeking eligible participants. The initial posting of the study occurred on May 24th, 2023, and it was last updated on January 18th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

Ernest Pedapati, MD 2023. "Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227780.

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