[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05289934":3,"trial-entities:NCT05289934":100,"trial-summary:NCT05289934":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":61,"locations":63,"central_contacts":79,"overall_officials":82,"references":85,"see_also_links":99},"NCT05289934","IRB00260509","Effects of Recorded Music on Clinical and EEG Seizure Activity","Effects of Recorded Music on Clinical and Electroencephalography (EEG) Seizure Activity","RECRUITING","2027-03-01","2026-03","2026-03-06","2023-04-22","Johns Hopkins University","OTHER",false,"This research is being done to determine if Mozart music and\u002For age-appropriate music can reduce the frequency of seizures and epileptiform discharges.","Several prospective studies have demonstrated the impact of Mozart's sonata for Two Pianos (K.448) on interictal epileptiform discharges and\u002For clinical seizure recurrence in children with epilepsy. While the exact mechanisms by which Mozart music has this effect are not yet established, there continues to be growing evidence demonstrating the positive effects on Mozart music upon seizure frequency and epileptiform discharges. Additional studies are needed to further elucidate the effect of Mozart music on epilepsy given the heterogeneity of protocols used in diverse clinical settings, with the goal of using these findings to drive potential therapy in the clinical setting.\n\nTherefore, this study will explore if there are differences in epileptiform activity and clinical seizures between Mozart K.448, instrumental age-appropriate songs, and a patient's baseline activity during EMU stays. The children (age 4-17 yrs.) will listen to Mozart K.448 (1st movement) and instrumental age-appropriate songs with washout (10 minutes) in between, each lasting up to 9 minutes in the daytime. The music stimuli will be randomly played in 2 to 7 EMU stay days (average length of stay 4 days) and delivered via single-use earbuds. As per standard clinical care the investigators will monitor continuous video electroencephalography (EEG) in the epilepsy monitoring unit.\n\nThe frequency of epileptiform discharges (e.g., the number of spikes per 100 seconds, the number of seconds with spikes, and clinical seizures) will be counted before, during, and after music procedures. Heart rate variability and blood pressure will also be measured before, during, and after music stimuli to understand associations between physiological responses and epileptiform discharges to musical stimuli. Participants' behavior changes will be recorded.",[19],"Epilepsy",[19,21,22],"Electroencephalography (EEG)","Music","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},10,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Music Stimuli","Nine-minute-long Mozart K.448 (1st movement) and instrumental age-appropriate songs will be played via single-use earbuds with 10 minutes wash-out in between music stimuli.",[36],"Children with Epilepsy",[38,42],{"measure":39,"description":40,"timeFrame":41},"Change in the frequency of epileptiform discharges (number of spikes)","The number of spikes in 100 seconds will be counted.","Epilepsy Monitoring Units Stay (up to Day 7)",{"measure":43,"description":44,"timeFrame":41},"Change in the frequency of epileptiform discharges (number of seconds with spikes)","The number of seconds with spikes will be measured.",[46,49],{"measure":47,"description":48,"timeFrame":41},"Change in heart rate variability (HRV)","Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats.",{"measure":50,"description":51,"timeFrame":41},"Change in blood pressure variability (BPV)","The determinants of BPV are calculated for both systolic and diastolic blood pressure using \"the indices standard deviation (SD), average real variability (ARV), and coefficient of variation (CV)\" of all 3 measurement methods. The CV is obtained by dividing the SD by the average Blood Pressure (BP) level. The ARV is calculated as the average of the differences between consecutive BP measurements. SD, ARV and CV will be combined to report BPV. The unit of BPV is mmHg.","ALL","4 Years","17 Years",{"inclusion":56,"exclusion":58,"raw_text":60},[57],"Children (age: 4 - 17 years old) who stay at Epilepsy Monitoring Units (EMU) up to 7 days may join.",[59],"Non-English Speaking","Inclusion Criteria:\n\n* Children (age: 4 - 17 years old) who stay at Epilepsy Monitoring Units (EMU) up to 7 days may join.\n\nExclusion Criteria:\n\n* Non-English Speaking",[62],"CHILD",[64],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"Johns Hopkins School of Medicine","Baltimore","Maryland","21205","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Sarah Kelley, MD","CONTACT","410-955-9100","saminof1@jhmi.edu",{"lat":77,"lon":78},39.29038,-76.61219,[80],{"name":72,"role":73,"phone":81,"email":75},"4109559100",[83],{"name":72,"affiliation":13,"role":84},"PRINCIPAL_INVESTIGATOR",[86,90,93,96],{"pmid":87,"type":88,"citation":89},"29034226","BACKGROUND","Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389\u002Ffpubh.2017.00258. eCollection 2017.",{"pmid":91,"type":88,"citation":92},"29040398","Abellan-Huerta J, Prieto-Valiente L, Montoro-Garcia S, Abellan-Aleman J, Soria-Arcos F. Correlation of Blood Pressure Variability as Measured By Clinic, Self-measurement at Home, and Ambulatory Blood Pressure Monitoring. Am J Hypertens. 2018 Feb 9;31(3):305-312. doi: 10.1093\u002Fajh\u002Fhpx183.",{"pmid":94,"type":88,"citation":95},"29696618","Hernando-Requejo V. [Epilepsy, Mozart and his sonata K.448: is the \u003C\u003CMozart effect>> therapeutic?]. Rev Neurol. 2018 May 1;66(9):308-314. Spanish.",{"pmid":97,"type":88,"citation":98},"31488774","Bedetti C, Principi M, Di Renzo A, Muti M, Frondizi D, Piccirilli M, D'Alessandro P, Marchiafava M, Baglioni A, Menna M, Gubbiotti M, Elisei S. The Effect of Mozart's Music in Severe Epilepsy: Functional and Morphological Features. Psychiatr Danub. 2019 Sep;31(Suppl 3):467-474.",[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"Seizure Disorder",[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This interventional study plans to enroll 10 participants. Music stimuli will be randomly played during the EMU stay.","completed","Music and Seizure Activity in Children with Epilepsy","This study is looking at whether listening to Mozart music or other age-appropriate instrumental songs can help reduce seizures and unusual brain activity (epileptiform discharges) in children with epilepsy. Researchers will play specific music through earbuds for short periods while children are staying in an Epilepsy Monitoring Unit (EMU). They will then compare changes in seizure frequency and brain activity to see if the music has a positive effect. The study aims to enroll 10 children aged 4 to 17 years old who are staying in an EMU. The study is currently unclear about its recruitment status.","Changes in seizure activity will be measured during your Epilepsy Monitoring Unit stay, which can last up to 7 days.",97,"You would listen to Mozart K.448 and age-appropriate instrumental songs via earbuds for up to 9 minutes each, with a 10-minute break in between, during your EMU stay.","Not stated in the trial record.",[],"v2"]