StrokeMUKU2NCT01749709
Effect of Daily Music Listening on Stroke Recovery
A study testing Music listening and Audiobook listening in people with Stroke, run by Turku University Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Music listening and Audiobook listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2012to 5 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Hemispheral stroke
Who cannot join
- Previous neurological or current psychiatric disease,
- severe aphasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Please see above
- Conditions
- Stroke
- Being tested
- Music listening, Audiobook listening
- Keywords
- Stroke, Recovery, Music
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
Audiobook listeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Instrumental music listening | Experimental | Daily music listening Receives: Behavioral: Music listening |
| Vocal music listening | Experimental | Daily music listening Receives: Behavioral: Music listening |
| Audiobook listening (control) | Active comparator | Daily audiobook listening Receives: Behavioral: Audiobook listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropsychological performance (verbal memory)
Verbal memory summary score (Rivermead Behavioral Memory Test (RBMT) story recall, auditory-verbal learning task)
Measured: From acute to 3-month-stage
Change in neuropsychological performance (verbal memory)
Verbal memory summary score (RBMT story recall, auditory-verbal learning task)
Measured: From acute to 6-month-stage
Secondary outcomes (20)
Change in neuropsychological performance (Language skill)
Verbal fluency task
Measured: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Naming test CERAD/Boston Naming Test (BNT)
Measured: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Short Token Test
Measured: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Verbal fluency task
Measured: From acute to 6-month-stages
Change in neuropsychological performance (Language skill)
Naming test CERAD/BNT
Measured: From acute to 6-month-stages
Change in neuropsychological performance (Language skill)
Short Token Test
Measured: From acute to 6-month-stages
Change in mood
Profile of Mood States
Measured: From acute to 3-month-stage
Change in mood
Profile of Mood States
Measured: From acute to 6-month-stage
Change in structural gray matter
Voxel-based morphometry
Measured: From acute to 3-month-stage
Change in structural gray matter changes
Voxel-based morphometry
Measured: From acute to 6-month-stage
Change in structural white matter
Diffusion-weighted imaging
Measured: From acute to 3-month stage
Change in structural white matter
Diffusion-weighted imaging
Measured: From acute to 6-month stage
Change in neuronal function
Resting state/task-based fMRI
Measured: From acute to 3-month stage
Change in neuronal function
Resting state/task-based fMRI
Measured: From acute to 6-month stage
Change in physiological stress level
Cortisol serum concentration
Measured: From acute to 3-month-stage
Change in physiological stress level
Cortisol serum concentration
Measured: From acute to 6-month-stage
Change in physiological stress level
Beta-endorphin serum concentration
Measured: From acute to 3-month-stage
Change in physiological stress level
Beta-endorphin serum concentration
Measured: From acute to 6-month-stage
Change in physiological stress level
Oxytocin serum concentration
Measured: From acute to 3-month-stage
Change in physiological stress level
Oxytocin serum concentration
Measured: From acute to 6-month-stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completion5 Apr 2016
- Study completion5 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Academy of Finland
- Responsible party
- Sponsor
- Investigators
- Valtteri Kaasinen, MD, Study chair, Department of Clinical Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749709
- Sponsor's protocol ID
- 85/180/2011
- Acronym
- MUKU2
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2012
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Stimulation on Recovery After Stroke
- ClinicalTrials.gov ID
- NCT01749709
- Acronym / sponsor ID
- MUKU2 / 85/180/2011
- Conditions
- Stroke
- Keywords
- Stroke, Recovery, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Academy of Finland
- Study start
- Dec 2012
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- 5 Apr 2016 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instrumental music listening | Experimental | Behavioral: Music listeningDaily music listening |
| Vocal music listening | Experimental | Behavioral: Music listeningDaily music listening |
| Audiobook listening (control) | Active comparator | Behavioral: Audiobook listeningDaily audiobook listening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Hemispheral stroke
Key exclusion criteria (2 listed)
- Previous neurological or current psychiatric disease,
- severe aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listening | Behavioural | Instrumental music listening, Vocal music listening |
| Audiobook listening | Behavioural | Audiobook listening (control) |
Primary outcome
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)
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)
20 secondary outcomes
Change in neuropsychological performance (Language skill)
Time frame: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Time frame: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Time frame: From acute to 3-month-stage
Change in neuropsychological performance (Language skill)
Time frame: From acute to 6-month-stages
Change in neuropsychological performance (Language skill)
Time frame: From acute to 6-month-stages
Change in neuropsychological performance (Language skill)
Time frame: From acute to 6-month-stages
Change in mood
Time frame: From acute to 3-month-stage
Change in mood
Time frame: From acute to 6-month-stage
Change in structural gray matter
Time frame: From acute to 3-month-stage
Change in structural gray matter changes
Time frame: From acute to 6-month-stage
Change in structural white matter
Time frame: From acute to 3-month stage
Change in structural white matter
Time frame: From acute to 6-month stage
Change in neuronal function
Time frame: From acute to 3-month stage
Change in neuronal function
Time frame: From acute to 6-month stage
Change in physiological stress level
Time frame: From acute to 3-month-stage
Change in physiological stress level
Time frame: From acute to 6-month-stage
Change in physiological stress level
Time frame: From acute to 3-month-stage
Change in physiological stress level
Time frame: From acute to 6-month-stage
Change in physiological stress level
Time frame: From acute to 3-month-stage
Change in physiological stress level
Time frame: From acute to 6-month-stage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valtteri Kaasinen, MD study chair
Department of Clinical Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening and Audiobook listening in people with Stroke, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropsychological performance (verbal memory) (time frame: From acute to 3-month-stage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.