search
Back to results

Effect of Daily Music Listening on Stroke Recovery (MUKU2)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Music listening
Audiobook listening
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Recovery, Music

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute Hemispheral stroke

Exclusion Criteria:

  • Previous neurological or current psychiatric disease,
  • severe aphasia

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Instrumental music listening

Vocal music listening

Audiobook listening (control)

Arm Description

Daily music listening

Daily music listening

Daily audiobook listening

Outcomes

Primary Outcome Measures

Change in neuropsychological performance (verbal memory)
Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task)
Change in neuropsychological performance (verbal memory)
Verbal memory summary score (RBMT story recall, auditory-verbal learning task)

Secondary Outcome Measures

Change in neuropsychological performance (Language skill)
Verbal fluency task
Change in neuropsychological performance (Language skill)
Naming test CERAD/Boston Naming Test (BNT)
Change in neuropsychological performance (Language skill)
Short Token Test
Change in neuropsychological performance (Language skill)
Verbal fluency task
Change in neuropsychological performance (Language skill)
Naming test CERAD/BNT
Change in neuropsychological performance (Language skill)
Short Token Test
Change in mood
Profile of Mood States
Change in mood
Profile of Mood States
Change in structural gray matter
Voxel-based morphometry
Change in structural gray matter changes
Voxel-based morphometry
Change in structural white matter
Diffusion-weighted imaging
Change in structural white matter
Diffusion-weighted imaging
Change in neuronal function
Resting state/task-based fMRI
Change in neuronal function
Resting state/task-based fMRI
Change in physiological stress level
Cortisol serum concentration
Change in physiological stress level
Cortisol serum concentration
Change in physiological stress level
Beta-endorphin serum concentration
Change in physiological stress level
Beta-endorphin serum concentration
Change in physiological stress level
Oxytocin serum concentration
Change in physiological stress level
Oxytocin serum concentration

Full Information

First Posted
December 12, 2012
Last Updated
December 31, 2021
Sponsor
Turku University Hospital
Collaborators
Academy of Finland
search

1. Study Identification

Unique Protocol Identification Number
NCT01749709
Brief Title
Effect of Daily Music Listening on Stroke Recovery
Acronym
MUKU2
Official Title
Effect of Cognitive Stimulation on Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 5, 2016 (Actual)
Study Completion Date
April 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Academy of Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Please see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Recovery, Music

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instrumental music listening
Arm Type
Experimental
Arm Description
Daily music listening
Arm Title
Vocal music listening
Arm Type
Experimental
Arm Description
Daily music listening
Arm Title
Audiobook listening (control)
Arm Type
Active Comparator
Arm Description
Daily audiobook listening
Intervention Type
Behavioral
Intervention Name(s)
Music listening
Intervention Type
Behavioral
Intervention Name(s)
Audiobook listening
Primary Outcome Measure Information:
Title
Change in neuropsychological performance (verbal memory)
Description
Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task)
Time Frame
From acute to 3-month-stage
Title
Change in neuropsychological performance (verbal memory)
Description
Verbal memory summary score (RBMT story recall, auditory-verbal learning task)
Time Frame
From acute to 6-month-stage
Secondary Outcome Measure Information:
Title
Change in neuropsychological performance (Language skill)
Description
Verbal fluency task
Time Frame
From acute to 3-month-stage
Title
Change in neuropsychological performance (Language skill)
Description
Naming test CERAD/Boston Naming Test (BNT)
Time Frame
From acute to 3-month-stage
Title
Change in neuropsychological performance (Language skill)
Description
Short Token Test
Time Frame
From acute to 3-month-stage
Title
Change in neuropsychological performance (Language skill)
Description
Verbal fluency task
Time Frame
From acute to 6-month-stages
Title
Change in neuropsychological performance (Language skill)
Description
Naming test CERAD/BNT
Time Frame
From acute to 6-month-stages
Title
Change in neuropsychological performance (Language skill)
Description
Short Token Test
Time Frame
From acute to 6-month-stages
Title
Change in mood
Description
Profile of Mood States
Time Frame
From acute to 3-month-stage
Title
Change in mood
Description
Profile of Mood States
Time Frame
From acute to 6-month-stage
Title
Change in structural gray matter
Description
Voxel-based morphometry
Time Frame
From acute to 3-month-stage
Title
Change in structural gray matter changes
Description
Voxel-based morphometry
Time Frame
From acute to 6-month-stage
Title
Change in structural white matter
Description
Diffusion-weighted imaging
Time Frame
From acute to 3-month stage
Title
Change in structural white matter
Description
Diffusion-weighted imaging
Time Frame
From acute to 6-month stage
Title
Change in neuronal function
Description
Resting state/task-based fMRI
Time Frame
From acute to 3-month stage
Title
Change in neuronal function
Description
Resting state/task-based fMRI
Time Frame
From acute to 6-month stage
Title
Change in physiological stress level
Description
Cortisol serum concentration
Time Frame
From acute to 3-month-stage
Title
Change in physiological stress level
Description
Cortisol serum concentration
Time Frame
From acute to 6-month-stage
Title
Change in physiological stress level
Description
Beta-endorphin serum concentration
Time Frame
From acute to 3-month-stage
Title
Change in physiological stress level
Description
Beta-endorphin serum concentration
Time Frame
From acute to 6-month-stage
Title
Change in physiological stress level
Description
Oxytocin serum concentration
Time Frame
From acute to 3-month-stage
Title
Change in physiological stress level
Description
Oxytocin serum concentration
Time Frame
From acute to 6-month-stage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute Hemispheral stroke Exclusion Criteria: Previous neurological or current psychiatric disease, severe aphasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valtteri Kaasinen, MD
Organizational Affiliation
Department of Clinical Neurosciences
Official's Role
Study Chair
Facility Information:
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Effect of Daily Music Listening on Stroke Recovery

We'll reach out to this number within 24 hrs