Stroke Clinical Trial
— MUKU2Official title:
Effect of Cognitive Stimulation on Recovery After Stroke
NCT number | NCT01749709 |
Other study ID # | 85/180/2011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2012 |
Est. completion date | April 5, 2016 |
Verified date | December 2021 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 5, 2016 |
Est. primary completion date | April 5, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Acute Hemispheral stroke Exclusion Criteria: - Previous neurological or current psychiatric disease, - severe aphasia |
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital | Academy of Finland |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Change in neuropsychological performance (verbal memory) | Verbal memory summary score (RBMT story recall, auditory-verbal learning task) | From acute to 6-month-stage | |
Secondary | Change in neuropsychological performance (Language skill) | Verbal fluency task | From acute to 3-month-stage | |
Secondary | Change in neuropsychological performance (Language skill) | Naming test CERAD/Boston Naming Test (BNT) | From acute to 3-month-stage | |
Secondary | Change in neuropsychological performance (Language skill) | Short Token Test | From acute to 3-month-stage | |
Secondary | Change in neuropsychological performance (Language skill) | Verbal fluency task | From acute to 6-month-stages | |
Secondary | Change in neuropsychological performance (Language skill) | Naming test CERAD/BNT | From acute to 6-month-stages | |
Secondary | Change in neuropsychological performance (Language skill) | Short Token Test | From acute to 6-month-stages | |
Secondary | Change in mood | Profile of Mood States | From acute to 3-month-stage | |
Secondary | Change in mood | Profile of Mood States | From acute to 6-month-stage | |
Secondary | Change in structural gray matter | Voxel-based morphometry | From acute to 3-month-stage | |
Secondary | Change in structural gray matter changes | Voxel-based morphometry | From acute to 6-month-stage | |
Secondary | Change in structural white matter | Diffusion-weighted imaging | From acute to 3-month stage | |
Secondary | Change in structural white matter | Diffusion-weighted imaging | From acute to 6-month stage | |
Secondary | Change in neuronal function | Resting state/task-based fMRI | From acute to 3-month stage | |
Secondary | Change in neuronal function | Resting state/task-based fMRI | From acute to 6-month stage | |
Secondary | Change in physiological stress level | Cortisol serum concentration | From acute to 3-month-stage | |
Secondary | Change in physiological stress level | Cortisol serum concentration | From acute to 6-month-stage | |
Secondary | Change in physiological stress level | Beta-endorphin serum concentration | From acute to 3-month-stage | |
Secondary | Change in physiological stress level | Beta-endorphin serum concentration | From acute to 6-month-stage | |
Secondary | Change in physiological stress level | Oxytocin serum concentration | From acute to 3-month-stage | |
Secondary | Change in physiological stress level | Oxytocin serum concentration | From acute to 6-month-stage |
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