[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533589":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":89,"collaborators":92,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":38,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":56,"whyStopped":38,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Fragile X Syndrome","EXPERIMENTAL","Fragile X Syndrome with full FMR1 mutations (\\>200 CGG repeats; at least partial FMR1 gene methylation)",[13,14],"Other: Alpha Auditory Entrainment","Other: Sham",{"label":16,"type":17,"description":18,"interventionNames":19},"Autism Spectrum Disorder Controls","ACTIVE_COMPARATOR","Age and sex-matched with FXS cohort",[13,14],{"label":21,"type":17,"description":22,"interventionNames":23},"Typically Developing Controls","Subjects with neither disorder who have met normal developmental milestones",[13,14],[25,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Alpha Auditory Entrainment","Alpha Brainwave Entrainment (AAE) stimulus: starts at high theta range (7-Hz) through high alpha (13-Hz) in 2 Hz steps on a 500 Hz sine carrier tone\n\nTarget frequency: 10 Hz\n\nDelivery: headphones\u002Fspeakers",[16,9,21],[30,31,32,33],"Alpha Brainwave Entrainment","Alpha Binaural Beats","Pulsed Sound Stimulation","Sonic Entrainment",{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Sham","Sham stimulus: carrier tone alone\n\nTarget frequency: N\u002FA\n\nDelivery: headphones\u002Fspeakers",[16,9,21],null,[40],{"name":41,"affiliation":5,"role":42},"Ernest V Pedapati, MD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Jae Citarella","CONTACT","513-636-0875","Jae.Citarella@cchmc.org",{"name":50,"role":46,"phone":51,"phoneExt":38,"email":52},"Grace Westerkamp","513-636-2332","grace.westerkamp@cchmc.org",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45226","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-84.51439,39.12711,{"lat":66,"lon":65},[69,70,71,72,75,77,79,81,83,85,87],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},{"name":50,"role":46,"phone":38,"phoneExt":38,"email":52},{"name":41,"role":42,"phone":38,"phoneExt":38,"email":38},{"name":73,"role":74,"phone":38,"phoneExt":38,"email":38},"Craig Erickson, MD","SUB_INVESTIGATOR",{"name":76,"role":74,"phone":38,"phoneExt":38,"email":38},"Elizabeth Smith, PhD",{"name":78,"role":74,"phone":38,"phoneExt":38,"email":38},"Steve Wu, MD",{"name":80,"role":74,"phone":38,"phoneExt":38,"email":38},"Meredith Will, PhD",{"name":82,"role":74,"phone":38,"phoneExt":38,"email":38},"Rebecca Shaffer, PhD",{"name":84,"role":74,"phone":38,"phoneExt":38,"email":38},"Makoto Miyakoshi, PhD",{"name":86,"role":74,"phone":38,"phoneExt":38,"email":38},"Lauren Schmitt, PhD",{"name":88,"role":74,"phone":38,"phoneExt":38,"email":38},"Kelli Dominick, MD, PhD",{"type":42,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Ernest Pedapati, MD","Assistant Professor",[93],{"name":94,"class":95},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100533589","alpha-auditory-entrainment-for-cognitive-enhancement-and-sensory-hypersensitivity-in-youth-with-developmental-disorders-100533589",false,"NCT06227780","Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders","FX ENTRAIN: Perturbation of Neurodynamics Underlying Sensory Hyperarousal and Statistical Learning in Youth With FXS","ENTRAIN","Inclusion Criteria:\n\n* FXS Cohort: 1) Aged 5-10 years, inclusive; 2) Patient has full FMR1 mutation confirmed by genetic testing.\n* ASD Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator.\n* TDC Cohort: 1) Aged 5-10 years, inclusive; 2) Have no known genetic mutation; 3) Have documentation of ASD diagnosis; 4) Score ≤ 15 on SCQ screen; 5) Be in good health per investigator; 6) Patient has met normal developmental milestones; Patient has no family history of heritable neuropsychiatric disorders; 7) Patient has an IQ greater than 85 on the Stanford-Binet; 8) Score ≤8 on an SCQ screen.\n\nExclusion Criteria:\n\n* All subjects: 1) Patient has auditory or visual impairments that cannot be corrected; 2) History of substance abuse or dependence within the past 6 months",true,"ALL","5 Years","10 Years",{"count":109,"type":110},180,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.",[9,116,117,118],"Autism Spectrum Disorder","Autistic Disorder","Asperger Syndrome",[120,117,116,9,121,122,123,124,125],"Neurodevelopmental Disorders","Fragile X","FXS","ASD","Asperger","Autism","2026-03-25",{"date":128,"type":129},"2026-03-30","ACTUAL",{"date":131,"type":129},"2023-05-24",{"date":133,"type":110},"2028-05-24",{"name":5,"class":6},1]