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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