Therapeutic Music Listening in Post Stroke Patients: a Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Therapeutic Music Listening intervention
Experimental group subjected to a 4-week intervention of daily Therapeutic Music Listening sessions (Raglio, 2023) in addition to conventional therapeutic interventions (standard care)
干预措施: Music intervention (Other)
Control group
Control group subjected solely to conventional therapeutic interventions.
干预措施: Control group (Other)
结局指标
主要结局
Effectiveness of Therapeutic Music Listening (TML) on anxiety in post stroke patients
时间窗: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of anxiety, that will be measured using the Generalized Anxiety Disorder scale (GAD-7). In this scale scores range from 0 to 21 with higher scores indicating more severe GAD symptoms.
Effectiveness of Therapeutic Music Listening (TML) on depression in post stroke patients
时间窗: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of depression, that will be measured using the Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 with higher scores indicating more severe PHQ symptoms.
Effectiveness of Therapeutic Music Listening (TML) on quality of life in post stroke patients
时间窗: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of quality of life, that will be measured using the EuroQol-5D (EQ-5D). Scores are of two types: the Utility Index (EQ-5D Index), that represents the ratio between health state and social utility, and the Visual Analogue Scale (EQ-VAS) that represents the subjective self-perception of health. The EQ-5D Index ranges from 0.000 to 1.000 with the latter indicating "full health" and the EQ-VAS ranges from 0 to 100 with the latter indicating the best state of health.
Effectiveness of Therapeutic Music Listening (TML) on cognitive outcomes in post stroke patients
时间窗: Time Frame: From enrollment (T0) to the end of treatment at 4 weeks (T1) and follow-up at 8 weeks (T2).
To evaluate the impact of Therapeutic Music Listening on the improvement of cognitive outocomes (with particular focus on Memory and Attention), that will be measured using the Monteral Cognitive Assessment (MoCA). Scores range from 0 to 30 with scores of 26 or above considered normal.
次要结局
- fMRI investigation on the resting-state brain activity modifications(From enrollment to end of treatment at 4 weeks.)
- fMRI investigation on the brain macrostructure modifications(From enrollment to end of treatment at 4 weeks.)