Effect of Daily Music Listening on Stroke Recovery (MUKU2)

December 31, 2021 updated by: Turku University Hospital

Effect of Cognitive Stimulation on Recovery After Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Please see above

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute Hemispheral stroke

Exclusion Criteria:

  • Previous neurological or current psychiatric disease,
  • severe aphasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From acute to 3-month-stage
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)
From acute to 6-month-stage

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Academy of Finland

Investigators

  • Study Chair: Valtteri Kaasinen, MD, Department of Clinical Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

April 5, 2016

Study Completion (Actual)

April 5, 2016

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85/180/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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