[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06425029":3,"trial-entities:NCT06425029":152,"trial-summary:NCT06425029":156},{"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":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":50,"secondary_outcomes":55,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":92,"locations":95,"central_contacts":138,"overall_officials":141,"references":143,"see_also_links":151},"NCT06425029","STUDY02002411","Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application","SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application","RECRUITING","2027-12","2026-05","2026-05-20","2025-07-22","Dartmouth-Hitchcock Medical Center","OTHER",false,"This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.","This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music.\n\nIt is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation.\n\nPrimary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends.\n\nSecondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece.\n\nThis study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.",[19,20,21],"Epilepsy","Refractory Epilepsy","Music",[23,24,25,26],"music","epilepsy","responsive neurostimulation","interictal discharge","INTERVENTIONAL","BASIC_SCIENCE",[30],"NA",{"count":32,"type":33},24,"ESTIMATED",[35,40,45],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Experimental Intervention (Music A)","Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.",[39],"Music Piece A",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Active Comparator Intervention (Music B)","Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.",[44],"Music Piece B",{"type":14,"name":46,"description":47,"armGroupLabels":48},"Active Comparator Intervention (Music C)","Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.",[49],"Music Piece C",[51],{"measure":52,"description":53,"timeFrame":54},"Music Intervention and its effects on epileptic activity in human brain","This measure aims to determine if specific music intervention has positive effect on epileptic activity in participants with responsive neurostimulation device (RNS) implanted for drug-resistant epilepsy (DRE). The effect will be measured as a change in the number of \"long episodes\" or epileptic activity in a participants' brain as detected and recorded by the RNS device before and after study music interventions.","Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1\u002F2 Months)",[56,60,63,66,69,72,75],{"measure":57,"description":58,"timeFrame":59},"Reduction in patient-reported seizures","The study team will collect and assess the number of seizures reported by participants during the 4-week period before enrollment (retrospective or going back in time) and 4 1\u002F2 months throughout the study (prospective or going forward in time).","Throughout the study completion, an average of 5 1\u002F2 months (4 weeks retrospective data collection and 4 1\u002F2 months post enrollment)",{"measure":61,"description":62,"timeFrame":59},"Determining duration of therapeutic effect of music intervention","The study team will assess the time frame (seconds, hours, days, weeks, etc.) during which the reduction of \"long episodes\" or epileptic activity in participants' brain, as detected by the RNS system, lasts after each music intervention.",{"measure":64,"description":65,"timeFrame":59},"Assessment of pre- and post-intervention cognition scores (BRIEF-A)","The study team will measure this outcome by comparing the difference in individual scores collected via cognition questionnaire (BRIEF-A) done by all participants before study intervention (Enrollment Visit) and at the end of the study (\"End of Study\" visit).",{"measure":67,"description":68,"timeFrame":59},"Assessment of pre- and post-intervention mood (DASS-21)","The study team will measure this outcome by comparing the difference in individual scores collected via mood questionnaire (DASS-21) done by all participants before study intervention (Enrollment Visit) and at the end of the study (\"End of Study\" visit).",{"measure":70,"description":71,"timeFrame":59},"Assessment of pre- and post-intervention quality of life (QOLIE-31)","The study team will measure this outcome by comparing the difference in individual scores collected via quality-of-life questionnaire (QOLIE-31) done by all participants before study intervention (Enrollment Visit) and at the end of the study (\"End of Study\" visit).",{"measure":73,"description":74,"timeFrame":59},"Assessment of music preferences pre- and post-intervention","The study team will review participants' responses to study specific music questionnaire. The outcome will be measured as percentage of participants and their specific musical preferences pre- and post-intervention.",{"measure":76,"description":77,"timeFrame":59},"Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy","The study team will assess participants' engagement with study interventions over the course of this study. This will be measured as a number of days each participant missed each music intervention.","ALL","18 Years",null,{"inclusion":82,"exclusion":87,"raw_text":91},[83,84,85,86],"Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation","Willing to attend all study visits and complete all required study procedures","Access to private or public wireless data service at regular intervals","Access to personal mobile device",[88,89,90],"Documentation of a musicogenic, or auditory-triggered focal seizure semiology","Participant is unable to reasonably participate in study tasks as determined by the investigator","Inability to obtain informed consent from the patient or legally authorized representative","Inclusion Criteria:\n\n* Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation\n* Willing to attend all study visits and complete all required study procedures\n* Access to private or public wireless data service at regular intervals\n* Access to personal mobile device\n\nExclusion Criteria:\n\n* Documentation of a musicogenic, or auditory-triggered focal seizure semiology\n* Participant is unable to reasonably participate in study tasks as determined by the investigator\n* Inability to obtain informed consent from the patient or legally authorized representative",[93,94],"ADULT","OLDER_ADULT",[96,119],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":116},"University of Massachusetts Chan Medical School","NOT_YET_RECRUITING","Worcester","Massachusetts","01655","United States",[104,108,111,114],{"name":105,"role":106,"email":107},"CJ Hill","CONTACT","Charles.hill6@umassmed.edu",{"name":109,"role":106,"email":110},"Natalie Erlich-Malona, MD","Natalie.Erlich-Malona@umassmemorial.org",{"name":112,"role":113},"Felicia Chu, MD","SUB_INVESTIGATOR",{"name":109,"role":115},"PRINCIPAL_INVESTIGATOR",{"lat":117,"lon":118},42.26259,-71.80229,{"facility":13,"status":8,"city":120,"state":121,"zip":122,"country":102,"contacts":123,"geoPoint":135},"Lebanon","New Hampshire","03756",[124,128,132,133],{"name":125,"role":106,"phone":126,"email":127},"Anastasia Kanishcheva, MPH","603-650-0260","Anastasia.Kanishcheva@Hitchcock.ORG",{"name":129,"role":106,"phone":130,"email":131},"Brian C Fidali, MD","603-650-5104","Brian.C.Fidali@hitchcock.org",{"name":129,"role":115},{"name":134,"role":113},"Barbara C Jobst, MD",{"lat":136,"lon":137},43.64229,-72.25176,[139,140],{"name":125,"role":106,"phone":126,"email":127},{"name":129,"role":106,"phone":130,"email":131},[142],{"name":129,"affiliation":13,"role":115},[144,148],{"pmid":145,"type":146,"citation":147},"34531410","BACKGROUND","Quon RJ, Casey MA, Camp EJ, Meisenhelter S, Steimel SA, Song Y, Testorf ME, Leslie GA, Bujarski KA, Ettinger AB, Jobst BC. Musical components important for the Mozart K448 effect in epilepsy. Sci Rep. 2021 Sep 16;11(1):16490. doi: 10.1038\u002Fs41598-021-95922-7.",{"pmid":149,"type":146,"citation":150},"35688855","Feng Y, Quon RJ, Jobst BC, Casey MA. Evoked responses to note onsets and phrase boundaries in Mozart's K448. Sci Rep. 2022 Jun 10;12(1):9632. doi: 10.1038\u002Fs41598-022-13710-3.",[],{"nct_id":4,"conditions":153,"biomarkers":155},[154],"Seizure Disorder",[],{"nct_id":4,"found":157,"summary":158,"prompt_version":168},true,{"design":159,"status":160,"heading":161,"summary":162,"follow_up":163,"word_count":164,"commitments":165,"compensation":166,"drugs_mentioned":167},"This is a placebo-controlled, double-blinded randomized study, meaning neither you nor the researchers will know which music you are listening to. It plans to include 24 participants.","completed","Music Therapy for Refractory Epilepsy","This study is testing if listening to specific music can help reduce epileptic activity in adults with epilepsy that hasn't responded well to other treatments (medication-refractory focal epilepsy). You would listen to Music A, Music B, or Music C daily on your own device. Researchers will compare how these different types of music affect your brain activity, specifically looking for a reduction in epileptic episodes. To join, you must be an adult with medication-refractory focal epilepsy, have had a NeuroPace Responsive Neurostimulator (RNS) device implanted for at least six months, and be on a stable RNS treatment plan. The study aims to enroll 24 participants, but its current recruitment status is unclear.","The primary endpoint is measured over approximately 4 1\u002F2 months, with the effect of music intervention expected to last at least one week after each intervention period.",112,"You would listen to music daily on your personal device and attend all study visits, which will occur at Baseline, Week 3-4, Week 9-10, and Weeks 13-14 (approximately 4 1\u002F2 months).","Not stated in the trial record.",[],"v2"]