[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626174":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":29,"enrollmentInfo":69,"targetDuration":29,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":39,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic Music Listening intervention","EXPERIMENTAL","Experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care)",[13],"Other: Music intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Control group subjected solely to conventional therapeutic interventions.",[18],"Other: Control group",[20,26],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Music intervention","The intervention will be managed by a professional music therapist with the collaboration of an operator. The music therapist collects data on the clinical history and musical preferences of the patient, which are integrated with the use of specific musical parameters and structures to create personalized playlists lasting 40 minutes. Such playlists aim to reflect the musical tastes of the patient and at the same time to obtain therapeutic objectives inducing relaxation, activation or distraction, depending on the clinical needs. The listening sessions take place daily for one month at a time of day chosen with the patient, who listen to the playlist through the use of a tablet and headphones. The music therapist submits to the patient a brief questionnaire after the first listening and then weekly, to verify the impact of music listening and possibly modify the playlist in line with the patient's feedback and the evolution of the treatment.",[9],[25],"Therapeutic Music Listening",{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Standard treatment is based on daily rehab activities (physical therapy and\u002For occupational therapy) and weekly psychological support sessions.",[15],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Alfredo Raglio","CONTACT","+39 3387291944","alfredo.raglio@icsmaugeri.it",[37],{"facility":38,"status":39,"city":40,"state":29,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fondazione Salvatore Maugeri I.R.C.C.S.","RECRUITING","Pavia","27100","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],9.15917,45.19205,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":52,"phoneExt":29,"email":35},"+39 03825921",{"type":54,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[56],{"name":57,"class":58},"Armonica Onlus Foundation","UNKNOWN","100626174","therapeutic-music-listening-in-post-stroke-patients-100626174",false,"NCT07432204","Therapeutic Music Listening in Post Stroke Patients.","Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.","ML4STROKE","Inclusion Criteria:\n\n* Diagnosis of first ischemic or hemorrhagic stroke verified by Computerized Axial Tomography or Magnetic Resonance\n* Age above 18 years\n* Mini Mental State Examination ≥ 24\n* Latency from the event \\\u003C 3 months\n* Presence of clinically significant anxiety and\u002For depression (Generalized Anxiety Disorder and\u002For Patient Health Questionnaire ≥10)\n* Onset of acute event not more than 90 days prior to enrollment in the study\n\nExclusion Criteria:\n\n* Clinical instability\n* Lesions dated over 3 months from onset\n* Multiple or bilateral lesions\n* Mini Mental State Examination \\\u003C 24\n* Previous or concomitant neurological, psychiatric, or internal pathologies found in the year preceding the study that, in the judgment of the clinical investigator, may affect the psychological condition and\u002For interfere with study procedures\n* Behavioral\u002Fcognitive disorders that prevent adequate patient compliance with treatment\n* Therapeutic-rehabilitative treatments with music in the year preceding the study\n* Previous musical skills (training or musical practice lasting more than 3 years)\n* Refusal or impossibility to sign informed consent\n\nFor the subgroup of patients subjected to functional Magnetic Resonance, the following exclusion criteria will also be taken into account:\n\n* Incompatibility with the execution of the MRI investigation (e.g., ascertained or possible presence of metal in the body; claustrophobia; sickle cell anemia)\n* Inability to understand or provide informed consent for the execution of the MRI investigation","ALL","18 Years",{"count":70,"type":71},132,"ESTIMATED","INTERVENTIONAL",[74],"NA","Numerous studies have highlighted how individualized music listening favors motor, cognitive, and emotional recovery in post-stroke patients, stimulating neuroplasticity and cerebral connectivity. However, gaps persist regarding the standardization of protocols and the neural mechanisms involved. This study aims to bridge these gaps with a rigorous scientific approach, integrating clinical assessments and neuroimaging.\n\nThis is a multicenter randomized controlled single-blind trial. Subjects will be allocated into 2 groups: an experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care), and a control group subjected solely to conventional therapeutic interventions (standard care). A follow-up is scheduled for one month after the conclusion of treatment. The study duration is 24 months and the screening phase will be continuous until the conclusion of planned recruitment.\n\nPrimary objective of the study is to evaluate the efficacy of Therapeutic Music Listening (TML) on anxiety in post-stroke patients.\n\nSecondary objective of the study is to investigate other possible effects on depression, quality of life, cognitive aspects (specifically attention and memory), and on connectivity via functional Magnetic Resonance Imaging (fMRI).\n\nPrimary endpoint is the reduction of anxiety. Secondary endpoint is the improvement in depression, quality of life, cognitive functions, and cerebral connectivity parameters.",[77,78,79],"Post Stroke","Anxiety","Depression",[25,81,78,79,82,83,84,85],"Stroke","Neuroplasticity","fMRI","Cognitive functions","Connectivity","2026-02-18",{"date":88,"type":89},"2026-02-25","ACTUAL",{"date":91,"type":89},"2025-11-12",{"date":93,"type":71},"2027-12-31",{"name":5,"class":6},1]