Therapeutic Music Listening in Post Stroke Patients.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Clinical instability

Lesions dated over 3 months from onset

Multiple or bilateral lesions

Mini Mental State Examination < 24

Trial design

Treatments tested in this trial

  • Music intervention
  • Control group

Treatment groups

132 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

Armonica Onlus Foundation

Collaborator