RecruitingNot Applicable

Therapeutic Music Listening in Post Stroke Patients.

Italy132 participantsStarted 2025-11-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

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).

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).

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).

Trial details

NCT IDNCT07432204

SponsorIstituti Clinici Scientifici Maugeri SpA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Alfredo Raglio

+39 3387291944 alfredo.raglio@icsmaugeri.it

View on ClinicalTrials.gov More Post Stroke trials