Effect of Daily Music Listening on Stroke Recovery

Study Overview
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Brief Summary
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Single blind randomized clinical trial including 50 stroke patients to investigate the effect of daily music listening on behavioral, neural and physiological recovery. Patients are randomized (1:1:1) to listen instrumental or vocal music, or audiobooks (recorded book reading) (control). Outcome measures are change in neuropsychological tests, change in self-reported mood, structural and functional magnetic resonance imaging changes and hormonal changes performed at acute, 3-month and 6-month stages.

Detailed Description
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Please see above

Official Title
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Effect of Cognitive Stimulation on Recovery After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Music listening
* Behavioral: Audiobook listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Hemispheral stroke Exclusion Criteria: Previous neurological or current psychiatric disease, severe aphasia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Instrumental music listening<br>Daily music listening | Behavioral: Music listening<br> <br> |
| Experimental: Vocal music listening<br>Daily music listening | Behavioral: Music listening<br> <br> |
| Active Comparator: Audiobook listening (control)<br>Daily audiobook listening | Behavioral: Audiobook listening<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropsychological performance (verbal memory) | Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task) | From acute to 3-month-stage | 
| Change in neuropsychological performance (verbal memory) | Verbal memory summary score (RBMT story recall, auditory-verbal learning task) | From acute to 6-month-stage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropsychological performance (Language skill) | Verbal fluency task | From acute to 3-month-stage | 
| Change in neuropsychological performance (Language skill) | Naming test CERAD/Boston Naming Test (BNT) | From acute to 3-month-stage | 
| Change in neuropsychological performance (Language skill) | Short Token Test | From acute to 3-month-stage | 
| Change in neuropsychological performance (Language skill) | Verbal fluency task | From acute to 6-month-stages | 
| Change in neuropsychological performance (Language skill) | Naming test CERAD/BNT | From acute to 6-month-stages | 
| Change in neuropsychological performance (Language skill) | Short Token Test | From acute to 6-month-stages | 
| Change in mood | Profile of Mood States | From acute to 3-month-stage | 
| Change in mood | Profile of Mood States | From acute to 6-month-stage | 
| Change in structural gray matter | Voxel-based morphometry | From acute to 3-month-stage | 
| Change in structural gray matter changes | Voxel-based morphometry | From acute to 6-month-stage | 
| Change in structural white matter | Diffusion-weighted imaging | From acute to 3-month stage | 
| Change in structural white matter | Diffusion-weighted imaging | From acute to 6-month stage | 
| Change in neuronal function | Resting state/task-based fMRI | From acute to 3-month stage | 
| Change in neuronal function | Resting state/task-based fMRI | From acute to 6-month stage | 
| Change in physiological stress level | Cortisol serum concentration | From acute to 3-month-stage | 
| Change in physiological stress level | Cortisol serum concentration | From acute to 6-month-stage | 
| Change in physiological stress level | Beta-endorphin serum concentration | From acute to 3-month-stage | 
| Change in physiological stress level | Beta-endorphin serum concentration | From acute to 6-month-stage | 
| Change in physiological stress level | Oxytocin serum concentration | From acute to 3-month-stage | 
| Change in physiological stress level | Oxytocin serum concentration | From acute to 6-month-stage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Recovery, Music