RecruitingNot ApplicableNCT07432204

Therapeutic Music Listening in Post Stroke Patients.

Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

132 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether listening to therapeutic music can reduce anxiety and depression in people recovering from a stroke. **You may be eligible if...** - You have had your first stroke (either a blocked or bleeding stroke), confirmed by brain scan - Your stroke occurred within the past 3 months - You are 18 or older - Your memory and thinking are largely intact (scoring at least 24 on a standard cognitive test) - You are experiencing significant anxiety or depression following your stroke **You may NOT be eligible if...** - You have had a previous stroke - You have severe cognitive impairment - You do not have clinically significant anxiety or depression symptoms - Your stroke occurred more than 3 months ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMusic 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.

OTHERControl group

Standard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions.


Locations(1)

Fondazione Salvatore Maugeri I.R.C.C.S.

Pavia, Italy

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NCT07432204


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