- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501797
Choir Singing in Aphasia Rehabilitation
Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND: Singing is a highly stimulating and versatile activity for the brain, combining vocal-motor, auditory, linguistic, cognitive, emotional, and social brain processes, both in the left and right hemisphere. The capacity to sing is often preserved in aphasia after stroke, and singing-based methods, such as Melodic Intonation Therapy (MIT), can be effective in rehabilitating speech production in aphasics. Also emotionally and socially, singing could provide a powerful alternative channel for aphasic patients to express their emotions and interact with others, but the communal or group-level use of singing in aphasia rehabilitation has not been systematically studied.
AIMS: The purpose of the study is to determine the clinical and neural efficacy of a novel choir singing intervention in subacute/chronic aphasia. Specifically, the targeted outcomes are (i) verbal and vocal-motor skills, (ii) cognitive skills, (iii) emotional functioning and quality of life, (iv) caregiver psychological well-being, and (v) structural and functional neuroplasticity. In addition, the capacity of singing and music learning in aphasia is explored.
METHODS: Subjects are 60 stroke patients with at least minor aphasia (≥ 6 months post-stroke) and their family members (FMs, N = 60) from Helsinki area recruited to a cross-over RCT study. Participants are randomized to two groups [N = 60 in both (30 patients, 30 FMs)], which receive a 16-week choir intervention either during the first (AB group) or second (BA group) half of the follow-up. The intervention is a combination of group training, which utilizes a novel combination of traditional senior choir singing and MIT-like speech training protocols, and home training in which the choir material is trained with a tablet computer. All patients are evaluated at baseline, 5-month, and 9-month stages with language, cognitive, and auditory-music tests and questionnaires. Half of the patients (N = 30) also undergo electroencephalography (EEG) and structural and functional magnetic resonance imaging (s/fMRI). FMs are evaluated with questionnaires.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland
- Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
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Helsinki, Finland
- Helsinki-Uusimaa Aphasia and Stroke Association
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The following inclusion criteria are used in patient recruiment:
- age over 18
- Finnish-speaking
- time since stroke > 6 months
- at least minor non-fluent aphasia due to stroke (BDAE Aphasia Severity Rating scale score ≤ 4)
- no hearing deficit
- no severe cognitive impairment affecting comprehension (the patient is able to understand the purpose of the study and give an informed consent)
- no neurological / psychiatric co-morbidity or substance abuse
- ability to produce vocal sound (through singing or humming).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early singing intervention (AB)
Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.
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The singing-based rehabilitation is a combination of group-training (16 weeks, 1 x week, 90 min), which utilizes a novel combination of traditional senior choir singing and singing-based speech training protocols, and home training (16 weeks, ≥ 3 x week, ≥ 30 min) in which the choir material is trained with a tablet computer.
Standard care comprises all rehabilitation and care services (e.g.
speech therapy, physical and occupational therapy, neuropsychological rehabilitation) received by the patients in the Finnish health care system
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EXPERIMENTAL: Late singing intervention (BA)
Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.
|
The singing-based rehabilitation is a combination of group-training (16 weeks, 1 x week, 90 min), which utilizes a novel combination of traditional senior choir singing and singing-based speech training protocols, and home training (16 weeks, ≥ 3 x week, ≥ 30 min) in which the choir material is trained with a tablet computer.
Standard care comprises all rehabilitation and care services (e.g.
speech therapy, physical and occupational therapy, neuropsychological rehabilitation) received by the patients in the Finnish health care system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Communication ability
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Spontaneous speech production
Time Frame: Change from baseline at 5 months and 9 months
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Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Connected speech informativeness
Time Frame: Change from baseline at 5 months and 9 months
|
Percentage of correct information units (CIUs) produced in a picture description task
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Change from baseline at 5 months and 9 months
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Repetition of words and sentences
Time Frame: Change from baseline at 5 months and 9 months
|
Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Verbal agility
Time Frame: Change from baseline at 5 months and 9 months
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Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Naming and word finding
Time Frame: Change from baseline at 5 months and 9 months
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Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Verbal comprehension
Time Frame: Change from baseline at 5 months and 9 months
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Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive function (correct responses)
Time Frame: Change from baseline at 5 months and 9 months
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Simon Task: score (range 0-100, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Executive function (reaction times)
Time Frame: Change from baseline at 5 months and 9 months
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Simon Task: reaction time mean (ms)
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Change from baseline at 5 months and 9 months
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Attention (correct responses)
Time Frame: Change from baseline at 5 months and 9 months
|
Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Attention (reaction times)
Time Frame: Change from baseline at 5 months and 9 months
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Flexible Attention Test (FAT): reaction time mean (ms)
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Change from baseline at 5 months and 9 months
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Working memory
Time Frame: Change from baseline at 5 months and 9 months
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Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Verbal memory
Time Frame: Change from baseline at 5 months and 9 months
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Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Verbal learning
Time Frame: Change from baseline at 5 months and 9 months
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Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Singing ability
Time Frame: Change from baseline at 5 months and 9 months
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Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software
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Change from baseline at 5 months and 9 months
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Music perception
Time Frame: Change from baseline at 5 months and 9 months
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Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Functional stroke recovery
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Depression
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Mood
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Social interaction
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Caregiver burden
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Psychological stress of the caregiver
Time Frame: Change from baseline at 5 months and 9 months
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Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome)
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Change from baseline at 5 months and 9 months
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Electroencephalography (EEG)
Time Frame: Change from baseline at 5 months and 9 months
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Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks
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Change from baseline at 5 months and 9 months
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Structural magnetic resonance imaging (sMRI): MPRAGE sequence
Time Frame: Change from baseline at 5 months and 9 months
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Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions
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Change from baseline at 5 months and 9 months
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Structural magnetic resonance imaging (sMRI): DTI sequence
Time Frame: Change from baseline at 5 months and 9 months
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Structural connectivity of intra- and interhemispheric white matter tracts
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Change from baseline at 5 months and 9 months
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Functional magnetic resonance imaging (fMRI): resting-state
Time Frame: Change from baseline at 5 months and 9 months
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resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks
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Change from baseline at 5 months and 9 months
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Functional magnetic resonance imaging (fMRI): singing-related activity
Time Frame: Change from baseline at 5 months and 9 months
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task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs
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Change from baseline at 5 months and 9 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 306625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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