Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001968268
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
5/12/2018
Date last updated
10/05/2021
Date data sharing statement initially provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does listening to music improve your language after stroke?
Scientific title
To examine whether daily music listening in addition to usual care will result in superior aphasia recovery compared to usual care only, as measured by standard clinical language and communication assessments at 2-4 weeks, 3 months and 6 months post stroke-onset.
Secondary ID [1] 296287 0
NHMRC - APP1144599
Universal Trial Number (UTN)
Trial acronym
AMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia post stroke 309984 0
Condition category
Condition code
Stroke 308752 308752 0 0
Haemorrhagic
Stroke 308753 308753 0 0
Ischaemic
Neurological 308814 308814 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient cohort will be randomly assigned to either treatment (music listening) + usual care, or a usual care only control condition (stratified based on severity of language deficit).

Treatment Group:
• The participants assigned to the music listening intervention will be provided with an iPad mini and an Apple Music subscription with their own personalised playlist for the duration of their music listening treatment. An allied health professional (i.e., music therapist, speech pathologist, or allied health assistant), will guide playlist selection and instruct participants on how to access, and listen, to music on the device.
• Participants will be instructed to listen to at least 1 hour of music per day (with feedback of total daily listening time provided via the Play Time app). Specific details such as time of day listening occurred, duration of listening for each session, each date listening has taken place, and which songs were listened to are recorded within the Play Time app (with a weekly breakdown of listening activity available).
• All participants will also receive usual aphasia treatment delivered by their treating speech pathologists available in each specific health service in which the patient is recruited.
Intervention code [1] 312628 0
Rehabilitation
Intervention code [2] 312668 0
Treatment: Other
Comparator / control treatment
Control Group:
• 20 healthy, age and gender-matched controls will be scanned once to identify key regions normally activated in fMRI studies. This data will be critical for determining regions-of-interest and will determine whether normal or novel patterns of activity are observed in patients at each time-point.
• The control participants will also be screened using a brief 5-10 minute cognitive assessment, the Montreal Cognitive Assessment (MoCA), to exclude cognitive impairment.

Usual Care Treatment Group:
• All participants will receive usual aphasia treatment delivered by their treating speech pathologists available in each specific health service in which the patient is recruited.
• The type and amount of therapy provided will be determined by the treating clinician and will depend on aphasia severity, symptoms, stage post-stroke, and service resources.
• For ethical reasons, this group will be offered the option of receiving the music listening intervention after follow-up assessment from 6-9 months with another assessment at 9 months. This data will not be used in the primary statistical analysis of the trial but will be used for an exploratory secondary analysis to provide pre-post within-subject comparisons on the effect of music exposure in the chronic stage.
Control group
Active

Outcomes
Primary outcome [1] 307790 0
Change in Western Aphasia Battery - Revised Aphasia Quotient at 3 months post stroke compared to baseline (2-4 weeks post-stroke onset)
Timepoint [1] 307790 0
Baseline (2-6 weeks) to 3 months post-stroke onset
Secondary outcome [1] 352897 0
Change in Western Aphasia Battery - Revised Aphasia Quotient at 6 months post stroke compared to baseline (2-4 weeks post-stroke onset)
Timepoint [1] 352897 0
Baseline (2-4 weeks) to 6 months post-stroke onset
Secondary outcome [2] 352898 0
Change in functional MRI measure of language-related brain activity at baseline (2-4 weeks post-stroke onset) to 3 and 6 months post-stroke onset.
Timepoint [2] 352898 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [3] 352903 0
Change in naming (Philadelphia Naming Test) at 3, 6 months post stroke compared to baseline (2-4 weeks post-stroke onset)
Timepoint [3] 352903 0
Baseline (2-4 weeks) to 6 months post-stroke onset
Secondary outcome [4] 352919 0
Change in comprehension (Comprehensive Aphasia Test) at 3, 6 months post stroke onset compared to baseline.
Timepoint [4] 352919 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [5] 352920 0
Changes in language processing at 3, 6 months post stroke onset compared to baseline (based on Psycholinguistic Assessments of Language Processing in Aphasia subtests 5, 7, 8, 14 and 15).
Timepoint [5] 352920 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [6] 352921 0
Changes in cognition at 3, 6 months post stroke onset compared to baseline (based on Test of Everyday Attention, Montreal Cognition Assessment, Trail Making Test A & B, and The Repeatable Battery for the Assessment of Neuropsychological Status-Update A subtests 1, 9, and 10).
Timepoint [6] 352921 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [7] 352922 0
Changes in music and prosody (composite outcome score) at 3, 6 months post stroke onset compared to baseline (based on the Short Montreal Battery for the Evaluation of Amusia, Pitch Discrimination test-shortened, Montreal Battery of Emotional Prosody, and Music Engagement Questionnaires).
Timepoint [7] 352922 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [8] 352923 0
Changes in mood at 3, 6 months post stroke onset compared to baseline (based on the Dynamic Visual Analogue Mood Scale, Stroke Aphasic Depression Questionnaire, and Stroke and Aphasia Quality of Life Scale).
Timepoint [8] 352923 0
Baseline (2-4 weeks) to 6 months post-stroke onset.
Secondary outcome [9] 352952 0
Change in performance on cognitive and music measures and language changes (composite outcome score) at 3, 6 months post stroke onset compared to baseline (based on Test of Everyday Attention, Montreal Cognition Assessment, Trail Making Test A & B, and The Repeatable Battery for the Assessment of Neuropsychological Status-Update A subtests 1, 9, and 10, Raven's Progressive Matrices, Music Engagement Questionnaire, and the Pitch Discrimination test).
Timepoint [9] 352952 0
Baseline (2-4 weeks) to 6 months post-stroke onset.

Eligibility
Key inclusion criteria
People with Aphasia
1) Single left hemisphere stroke (as diagnosed by neurologist or physician and confirmed by MRI or CT) and speech or language impairment as identified by a speech pathologist or other relevant medical, nursing or allied health staff;
2) below the aphasia cut-off (93.8 AQ) on the Western Aphasia Battery-Revised (WAB-R);
3) medical stability;
4) able to complete a behavioural language, cognitive, mood, and music processing battery between 2-4 weeks post-stroke;
5) have sufficient vision and hearing to complete the imaging and behavioural tasks; and
6) proficient in English language prior to stroke.

Healthy Controls:
1. English as first language
2. Right Handed
3. Sufficient hearing and vision to complete the imaging and behavioural tasks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with Aphasia:
1) Any other neurological disease or disorder, mental illness, dementia, head trauma, alcoholism, cerebral tumour or abscess;
2) Participants will be excluded from scanning if they have any metals present in the body or other contraindications for MRI including claustrophobia, or if severe auditory comprehension deficits preclude them from following directions in the MRI scanner;
3) uncorrected vision or hearing impairment (confirmed with pure tone audiometry);
4) unable to access music playing device due to significant motor or cognitive deficits; and 5) major clinical depression or other mental health condition that may affect participation.

Healthy Controls;
1. Any brain/neurological disorder, mental illness, head trauma, alcoholism and cerebral tumor
2. Any contraindications for MRI - claustrophobia or metals present in the body e.g. pacemaker, heart valve, dental bridge, metal mesh implants/clips/wire sutures, hearing implant etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once meeting all eligibility criteria, the randomisation of subjects to treatment or usual care, will take place centrally using a computer program run by an off-site researcher independent of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
covariate adaptive random allocation will be employed, using the covariates of WAB-AQ severity level (mild: 93.7-66; moderate: 65-33; severe: 32-0)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will recruit 94 individuals with post-stroke aphasia meeting the above criteria in order to reach our target of 40 subjects per arm, accounting for an estimated attrition rate of 15% based on our pilot imaging study and that of Särkämö et al. (2014) which was 12%. Based on the large effect sizes observed in CI Särkämö’s preliminary work (vocal music versus audiobook at 3 months d = 1.36; at 6 months d = .91), our proposed sample will achieve >80% power with an alpha level of .05 for the primary outcome measure (language performance on the WAB).

Behavioural data:
To evaluate the effectiveness of music listening on aphasia recovery compared to usual care alone, linear mixed models will be implemented. We will use linear mixed models to compare differences in recovery between groups (music versus usual care) on each outcome measure at 3 months and 6 months, treating participants as random effects as per our previous work (Dignam et al., 2015). Aphasia severity and pre-treatment scores will be included as covariates in each model. Baseline characteristics of the two groups will be compared, with any significant differences being considered for modeling as additional covariates. Multiple regression analyses will be conducted to determine the relative contributions of language, cognitive, and mood variables to outcomes at 3 and 6 months, including group (music, usual care) as a factor (as per Dignam et al., 2016).

fMRI data:
Assuming a similar signal change to that for our pilot fMRI data (n=12, minimum 4.7% signal change when the Word>Nonword contrast was covaried with outcome, p < .05 corrected for multiple comparisons using height threshold of p<.001, and cluster threshold of 40 voxels), we will achieve greater than 80% power with our proposed sample of 40 individuals per group based on simulations for fMRI power estimates of Desmond and Glover (2002). These calculations are based on achieving sufficient power with the smallest effect observed for our chosen outcome measures.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/01/2019
Actual
22/08/2019
Date of last participant enrolment
Anticipated
Actual
14/03/2020
Date of last data collection
Anticipated
Actual
Sample size
Target
94
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12625 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 12626 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 12627 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 19379 0
Nambour General Hospital - Nambour
Recruitment hospital [5] 19380 0
Gympie Hospital - Gympie
Recruitment hospital [6] 19381 0
Caboolture Hospital - Caboolture
Recruitment hospital [7] 19382 0
Ipswich Hospital - Ipswich
Recruitment hospital [8] 19383 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [9] 19384 0
Brighton Health Campus - Brighton
Recruitment postcode(s) [1] 25047 0
4029 - Herston
Recruitment postcode(s) [2] 25048 0
4215 - Southport
Recruitment postcode(s) [3] 25049 0
4575 - Birtinya
Recruitment postcode(s) [4] 33958 0
4560 - Nambour
Recruitment postcode(s) [5] 33959 0
4570 - Gympie
Recruitment postcode(s) [6] 33960 0
4510 - Caboolture
Recruitment postcode(s) [7] 33961 0
4305 - Ipswich
Recruitment postcode(s) [8] 33962 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 33963 0
4017 - Brighton

Funding & Sponsors
Funding source category [1] 300878 0
Government body
Name [1] 300878 0
National Health and Medical Research Council (NHMRC)
Country [1] 300878 0
Australia
Primary sponsor type
Individual
Name
Professor David Copland
Address
UQ Centre for Clinical Research
Faculty of Medicine
Level 3, Building 71/918, Herston
The University of Queensland,
QLD, 4029
Country
Australia
Secondary sponsor category [1] 300442 0
None
Name [1] 300442 0
Address [1] 300442 0
Country [1] 300442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301653 0
Royal Brisbane & Women's Hospital HREC
Ethics committee address [1] 301653 0
Ethics committee country [1] 301653 0
Australia
Date submitted for ethics approval [1] 301653 0
27/09/2018
Approval date [1] 301653 0
21/11/2018
Ethics approval number [1] 301653 0
HREC/2018/QRBW/43699

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87670 0
Prof David Copland
Address 87670 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 3, Building 71/918, Herston
The University of Queensland
QLD, 4029
Country 87670 0
Australia
Phone 87670 0
+61 7 3346 5539
Fax 87670 0
Email 87670 0
[email protected]
Contact person for public queries
Name 87671 0
Tracy Roxbury
Address 87671 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 3, Building 71/918, Herston
The University of Queensland
QLD, 4029
Country 87671 0
Australia
Phone 87671 0
+61 7 3346 6110
Fax 87671 0
Email 87671 0
[email protected]
Contact person for scientific queries
Name 87672 0
David Copland
Address 87672 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 3, Building 71/918, Herston
The University of Queensland,
QLD, 4029
Country 87672 0
Australia
Phone 87672 0
+61 7 3346 5539
Fax 87672 0
Email 87672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD would be de-identified information about demographics, language performance, and brain scans.
When will data be available (start and end dates)?
This is not currently known as we have not made any submissions for specific IPD sharing. No end date determined.
Available to whom?
Only to those who have ethics approval for de-identified data sharing
Available for what types of analyses?
Likely to be large-scale regression type analyses looking at factors predicting recovery and treatment response.
How or where can data be obtained?
De-identified data would only be available to those researchers with ethics approval and is likely to be stored on secure password protected university data repositories.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.