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NCT06227780 · ClinicalTrials.gov registry record · NA
Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders
A NA study of Autism Spectrum Disorder and Autistic Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT06227780 is a NA study of Autism Spectrum Disorder and Autistic Disorder that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 180 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06227780, a NA study of Autism Spectrum Disorder and Autistic Disorder, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some important discoveries have been made. Research has shown that individuals with FXS process sounds differently than those in the typical population, and they also show baseline differences in brain activity, including high gamma activity, increased theta activity, and decreased alpha activity. The investigators' central hypothesis is that these alterations in brain activity (specifically alpha and gamma activity) impair the brain's ability to process new information, thereby impeding cognitive functioning and increasing sensory sensitivity. The investigators propose that auditory entrainment, a technique that involves playing special sounds through headphones, will normalize brain activity in individuals with FXS and lead to increased cognitive function and decreased sensory hypersensitivity.
Conditions Studied
Interventions
- OTHER Sham
- OTHER Alpha Auditory Entrainment
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2028-05-24 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06227780
The ClinicalTrials.gov registry entry for NCT06227780 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT06227780 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06227780 about?
NCT06227780 is a clinical study titled "Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders". Fragile X Syndrome (FXS) is a complex neurodevelopmental disorder caused by a mutation on the X chromosome. Scientists have investigated FXS extensively in both humans and animals. Thus far, phenotypic rescue in animal models has not resulted in treatment breakthroughs in humans, though some importa...
What is the current status of trial NCT06227780?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2023-05-24. Estimated completion is 2028-05-24.
What conditions does trial NCT06227780 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autistic Disorder, Fragile X Syndrome, Asperger Syndrome.
What interventions are being tested in trial NCT06227780?
The interventions under investigation include: Sham (OTHER), Alpha Auditory Entrainment (OTHER).
Who is sponsoring clinical trial NCT06227780?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06227780 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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