Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07432204
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Music Listening in Post Stroke Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter randomized controlled single-blind trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients', 'timeFrame': 'From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).', 'description': 'To evaluate the impact of Therapeutic Music Listening on the improvement of anxiety, that will be measured using the Generalized Anxiety Disorder scale (GAD-7). In this scale scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.'}, {'measure': 'Effectiveness of Therapeutic Music Listening (TML) on depression in post stroke patients', 'timeFrame': 'Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).', 'description': 'To evaluate the impact of Therapeutic Music Listening on the improvement of depression, that will be measured using the Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 with higher scores indicating more severe PHQ symptoms.'}, {'measure': 'Effectiveness of Therapeutic Music Listening (TML) on quality of life in post stroke patients', 'timeFrame': 'Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).', 'description': 'To evaluate the impact of Therapeutic Music Listening on the improvement of quality of life, that will be measured using the EuroQol-5D (EQ-5D). Scores are of two types: the Utility Index (EQ-5D Index), that represents the ratio between health state and social utility, and the Visual Analogue Scale (EQ-VAS) that represents the subjective self-perception of health. The EQ-5D Index ranges from 0.000 to 1.000 with the latter indicating "full health" and the EQ-VAS ranges from 0 to 100 with the latter indicating the best state of health.'}, {'measure': 'Effectiveness of Therapeutic Music Listening (TML) on cognitive outcomes in post stroke patients', 'timeFrame': 'Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).', 'description': 'To evaluate the impact of Therapeutic Music Listening on the improvement of cognitive outocomes (with particular focus on Memory and Attention), that will be measured using the Monteral Cognitive Assessment (MoCA). Scores range from 0 to 30 with scores of 26 or above considered normal.'}], 'secondaryOutcomes': [{'measure': 'fMRI investigation on the resting-state brain activity modifications', 'timeFrame': 'From enrollment to end of treatment at 4 weeks.', 'description': 'The main variable regarding resting-state brain activity will be the activation intensity within each individual voxel of the magnetic resonance images, inferred as a metric of functional connectivity between the Blood Oxygen Level Dependent (BOLD) contrast signal time series in each image voxel. This variable will consist of distinct intrinsic connectivity metrics, specifically: a) "seed-to-voxel" connectivity originating from auditory brain areas; b) connectivity between "resting-state networks" identified via multivariate analysis methods of the resting-state fMRI data.'}, {'measure': 'fMRI investigation on the brain macrostructure modifications', 'timeFrame': 'From enrollment to end of treatment at 4 weeks.', 'description': 'The main variable regarding brain macrostructure will be the contrast index between gray matter and white matter within each individual voxel of the magnetic resonance images (T1-weighted). The pre-processing and statistical analysis of these images will provide an index related to gray matter volume and density within each individual voxel.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapeutic Music Listening', 'Stroke', 'Anxiety', 'Depression', 'Neuroplasticity', 'fMRI', 'Cognitive functions', 'Connectivity'], 'conditions': ['Post Stroke', 'Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 3 months\n* Presence of clinically significant anxiety and/or depression (Generalized Anxiety Disorder and/or 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 \\< 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/or interfere with study procedures\n* Behavioral/cognitive 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'}, 'identificationModule': {'nctId': 'NCT07432204', 'acronym': 'ML4STROKE', 'briefTitle': 'Therapeutic Music Listening in Post Stroke Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'ML4STROKE-CTSM179-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Music Listening intervention', 'description': 'Experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care)', 'interventionNames': ['Other: Music intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Control group subjected solely to conventional therapeutic interventions.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Music intervention', 'type': 'OTHER', 'otherNames': ['Therapeutic Music Listening'], 'description': "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.", 'armGroupLabels': ['Therapeutic Music Listening intervention']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Standard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alfredo Raglio', 'role': 'CONTACT', 'email': 'alfredo.raglio@icsmaugeri.it', 'phone': '+39 03825921'}], 'facility': 'Fondazione Salvatore Maugeri I.R.C.C.S.', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Alfredo Raglio', 'role': 'CONTACT', 'email': 'alfredo.raglio@icsmaugeri.it', 'phone': '+39 3387291944'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Armonica Onlus Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}