Overview
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.
This 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.
Primary objective of the study is to evaluate the efficacy of Therapeutic Music Listening (TML) on anxiety in post-stroke patients.
Secondary 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).
Primary endpoint is the reduction of anxiety. Secondary endpoint is the improvement in depression, quality of life, cognitive functions, and cerebral connectivity parameters.
Eligibility
Inclusion Criteria:
- Diagnosis of first ischemic or hemorrhagic stroke verified by Computerized Axial Tomography or Magnetic Resonance
- Age above 18 years
- Mini Mental State Examination ≥ 24
- Latency from the event \< 3 months
- Presence of clinically significant anxiety and/or depression (Generalized Anxiety Disorder and/or Patient Health Questionnaire ≥10)
- Onset of acute event not more than 90 days prior to enrollment in the study
Exclusion Criteria:
- Clinical instability
- Lesions dated over 3 months from onset
- Multiple or bilateral lesions
- Mini Mental State Examination \< 24
- 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
- Behavioral/cognitive disorders that prevent adequate patient compliance with treatment
- Therapeutic-rehabilitative treatments with music in the year preceding the study
- Previous musical skills (training or musical practice lasting more than 3 years)
- Refusal or impossibility to sign informed consent
For the subgroup of patients subjected to functional Magnetic Resonance, the following exclusion criteria will also be taken into account:
- Incompatibility with the execution of the MRI investigation (e.g., ascertained or possible presence of metal in the body; claustrophobia; sickle cell anemia)
- Inability to understand or provide informed consent for the execution of the MRI investigation
