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Completed

NCT Number: NCT01749709

Effect of Daily Music Listening on Stroke Recovery

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, Finland

About this study

Please see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute Hemispheral stroke

Exclusion criteria

  • Previous neurological or current psychiatric disease,
  • severe aphasia

Treatment and study plan

Music listening

Behavioral

Audiobook listening

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Academy of Finland

Registry information

Official study title

Effect of Cognitive Stimulation on Recovery After Stroke

Acronym: MUKU2

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2012
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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