Therapeutic Music Listening in Post Stroke Patients.

Официальное название

Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.

Обзор

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.

Вмешательства

• Другое Music intervention
  The intervention will be managed by a professional music therapist with the collaboration of an operator. The music therapist collects data on the clinical history and musical preferences of the patient, which are integrated with the use of specific musical parameters and structures to create personalized playlists lasting 40 minutes. Such playlists aim to reflect the musical tastes of the patient and at the same time to obtain therapeutic objectives inducing relaxation, activation or distractio
• Другое Control group
  Standard treatment is based on daily rehab activities (physical therapy and/or occupational therapy) and weekly psychological support sessions.

Первичные конечные точки

• Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients [Срок оценки: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).]
• Effectiveness of Therapeutic Music Listening (TML) on depression in post stroke patients [Срок оценки: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).]
• Effectiveness of Therapeutic Music Listening (TML) on quality of life in post stroke patients [Срок оценки: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).]
• Effectiveness of Therapeutic Music Listening (TML) on cognitive outcomes in post stroke patients [Срок оценки: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).]

Вторичные конечные точки (2)

• fMRI investigation on the resting-state brain activity modifications [Срок оценки: From enrollment to end of treatment at 4 weeks.]
• fMRI investigation on the brain macrostructure modifications [Срок оценки: From enrollment to end of treatment at 4 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Salvatore Maugeri I.R.C.C.S. — Pavia

Идентификаторы

NCT: NCT07432204 · ML4STROKE-CTSM179-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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