Music Listening to Ease Anxiety in Stroke Survivors
Tests daily therapeutic music listening added to usual care in adults after stroke.
Key facts
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Where
- Pavia, ItalySee the site
- Trial code
- Registry title
- Therapeutic Music Listening in Post Stroke Patients.
- Status
- Recruiting
- People taking part
- 132 people, planned
- Started
- 12 Nov 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Music intervention
- Control group
- Record updated
- 25 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a first stroke less than 3 months ago and now have significant anxiety and/or depression. It tests daily music listening on top of standard care.
- Age
- Above 18 years
- Sex
- All sexes
- Disease stage
- First ischemic or hemorrhagic stroke confirmed by CT or MRI, with onset not more than 90 days before enrollment; clinically significant anxiety and/or depression (Generalized Anxiety Disorder and/or Patient Health Questionnaire ≥10); Mini Mental State Examination ≥ 24
- Earlier treatment
- Must not have had music-based therapy or rehabilitation treatments in the year before the study
Main reasons for not taking part
- Clinically unstable condition
- Multiple or bilateral brain lesions
- Other neurological, psychiatric or internal illness in the past year that may affect mood or the study
- More than 3 years of musical training or practice
- Cannot sign informed consent
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Previous musical skills (training or musical practice lasting more than 3 years)
- Behavioral/cognitive disorders that prevent adequate patient compliance with treatment
- Clinical instability
- Lesions dated over 3 months from onset
- Multiple or bilateral lesions
- Mini Mental State Examination < 24
- Therapeutic-rehabilitative treatments with music in the year preceding the study
- 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
Where in Italy
- Fondazione Salvatore Maugeri I.R.C.C.S.Pavia, ItalyContact: Alfredo RaglioTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Therapeutic Music Listening interventionTreatment being tested
Experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care)
Treatment: Music intervention
- Control groupTreatment being tested
Control group subjected solely to conventional therapeutic interventions.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
- Plain-language title
- Music Listening to Ease Anxiety in Stroke SurvivorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 25 February 2026