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Trial record 1 of 1 for:    NCT01749709
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Effect of Daily Music Listening on Stroke Recovery (MUKU2)

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ClinicalTrials.gov Identifier: NCT01749709
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : January 5, 2022
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Music listening Behavioral: Audiobook listening Not Applicable

Detailed Description:
Please see above
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Cognitive Stimulation on Recovery After Stroke
Study Start Date : December 2012
Actual Primary Completion Date : April 5, 2016
Actual Study Completion Date : April 5, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Instrumental music listening
Daily music listening
 Behavioral: Music listening
Experimental: Vocal music listening
Daily music listening
 Behavioral: Music listening
Active Comparator: Audiobook listening (control)
Daily audiobook listening
 Behavioral: Audiobook listening


Outcome Measures
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Primary Outcome Measures :
  1. Change in neuropsychological performance (verbal memory) [ Time Frame: From acute to 3-month-stage ]
    Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task)

  2. Change in neuropsychological performance (verbal memory) [ Time Frame: From acute to 6-month-stage ]
    Verbal memory summary score (RBMT story recall, auditory-verbal learning task)


Secondary Outcome Measures :
  1. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 3-month-stage ]
    Verbal fluency task

  2. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 3-month-stage ]
    Naming test CERAD/Boston Naming Test (BNT)

  3. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 3-month-stage ]
    Short Token Test

  4. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 6-month-stages ]
    Verbal fluency task

  5. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 6-month-stages ]
    Naming test CERAD/BNT

  6. Change in neuropsychological performance (Language skill) [ Time Frame: From acute to 6-month-stages ]
    Short Token Test

  7. Change in mood [ Time Frame: From acute to 3-month-stage ]
    Profile of Mood States

  8. Change in mood [ Time Frame: From acute to 6-month-stage ]
    Profile of Mood States

  9. Change in structural gray matter [ Time Frame: From acute to 3-month-stage ]
    Voxel-based morphometry

  10. Change in structural gray matter changes [ Time Frame: From acute to 6-month-stage ]
    Voxel-based morphometry

  11. Change in structural white matter [ Time Frame: From acute to 3-month stage ]
    Diffusion-weighted imaging

  12. Change in structural white matter [ Time Frame: From acute to 6-month stage ]
    Diffusion-weighted imaging

  13. Change in neuronal function [ Time Frame: From acute to 3-month stage ]
    Resting state/task-based fMRI

  14. Change in neuronal function [ Time Frame: From acute to 6-month stage ]
    Resting state/task-based fMRI

  15. Change in physiological stress level [ Time Frame: From acute to 3-month-stage ]
    Cortisol serum concentration

  16. Change in physiological stress level [ Time Frame: From acute to 6-month-stage ]
    Cortisol serum concentration

  17. Change in physiological stress level [ Time Frame: From acute to 3-month-stage ]
    Beta-endorphin serum concentration

  18. Change in physiological stress level [ Time Frame: From acute to 6-month-stage ]
    Beta-endorphin serum concentration

  19. Change in physiological stress level [ Time Frame: From acute to 3-month-stage ]
    Oxytocin serum concentration

  20. Change in physiological stress level [ Time Frame: From acute to 6-month-stage ]
    Oxytocin serum concentration


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Hemispheral stroke

Exclusion Criteria:

  • Previous neurological or current psychiatric disease,
  • severe aphasia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749709


Locations
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Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
Academy of Finland
Investigators
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Study Chair: Valtteri Kaasinen, MD Department of Clinical Neurosciences
More Information
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01749709    
Other Study ID Numbers: 85/180/2011
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: December 2021
Keywords provided by Turku University Hospital:
Stroke
Recovery
Music
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases