NCT07432204Recruiting
Therapeutic Music Listening in Post Stroke Patients.
Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 12 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Stroke
- NCT number
- NCT07432204
What you commit to
- Study type: Interventional
- Planned participants: 132
- From 12 Nov 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Behavioral/cognitive disorders that prevent adequate patient compliance with treatment
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Salvatore Maugeri I.R.C.C.S. Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.