Therapeutic music listening to aid recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.