Therapeutic music listening to aid recovery after stroke
Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
This trial will test whether a daily 4-week therapeutic music listening program added to standard rehabilitation helps adults recovering from a first stroke who have significant anxiety or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT07432204 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled single-blind trial will randomize adults with a first ischemic or hemorrhagic stroke to either a 4-week daily therapeutic music listening intervention plus standard care or to standard care alone. Clinical assessments and neuroimaging will be performed at baseline, after the intervention, and at a one-month follow-up to examine motor, cognitive, and emotional outcomes as well as neural connectivity changes. Participants must be within three months of stroke onset, have MMSE ≥24, and clinically significant anxiety or depression to enroll. The study is planned over 24 months with continuous screening across participating centers.
Who should consider this trial
Good fit: Adults over 18 within three months of a first ischemic or hemorrhagic stroke with MMSE ≥24 and clinically significant anxiety or depression, who can comply with daily sessions and attend site visits, are ideal candidates.
Not a fit: Patients with multiple or bilateral lesions, cognitive or behavioral impairment that prevents treatment adherence, clinical instability, lesions older than three months, or recent therapeutic music exposure are unlikely to benefit.
Why it matters
Potential benefit: If effective, the intervention could accelerate motor and cognitive recovery and reduce anxiety and depression by promoting neuroplasticity.
How similar studies have performed: Prior studies have reported benefits of individualized music listening for motor, cognitive, and emotional recovery and for stimulating neuroplasticity, but protocols and neural mechanisms remain incompletely standardized and confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pavia
- Fondazione Salvatore Maugeri I.R.C.C.S. — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Alfredo Raglio
- Email: alfredo.raglio@icsmaugeri.it
- Phone: +39 3387291944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.