Aphasia, Stroke
Conditions
Brief summary
This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design, half of the participants receive a 4-month singing intervention during the first half of the study and half of the participants during the second half of the study.
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.
Interventions
BEHAVIORALSinging-based rehabilitation
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.
OTHERStandard care
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
Sponsors
Helsinki University Central Hospital
Hospital District of Helsinki and Uusimaa
Helsinki-Uusimaa Aphasia and Stroke Association
Finnish Brain Association
Outloud Ltd
University of Barcelona
University of Melbourne
Harvard Medical School (HMS and HSDM)
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The following inclusion criteria are used in patient recruiment: 1. age over 18 2. Finnish-speaking 3. time since stroke \> 6 months 4. at least minor non-fluent aphasia due to stroke (BDAE Aphasia Severity Rating scale score ≤ 4) 5. no hearing deficit 6. no severe cognitive impairment affecting comprehension (the patient is able to understand the purpose of the study and give an informed consent) 7. no neurological / psychiatric co-morbidity or substance abuse 8. ability to produce vocal sound (through singing or humming).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication ability | Change from baseline at 5 months and 9 months | Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome) |
| Spontaneous speech production | Change from baseline at 5 months and 9 months | Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome) |
| Connected speech informativeness | Change from baseline at 5 months and 9 months | Percentage of correct information units (CIUs) produced in a picture description task |
| Repetition of words and sentences | 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) |
| Verbal agility | Change from baseline at 5 months and 9 months | Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome) |
| Naming and word finding | Change from baseline at 5 months and 9 months | Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome) |
| Verbal comprehension | Change from baseline at 5 months and 9 months | Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Singing ability | Change from baseline at 5 months and 9 months | Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software |
| Music perception | Change from baseline at 5 months and 9 months | Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome) |
| Functional stroke recovery | Change from baseline at 5 months and 9 months | Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome) |
| Depression | Change from baseline at 5 months and 9 months | Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome) |
| Mood | Change from baseline at 5 months and 9 months | Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome) |
| Social interaction | Change from baseline at 5 months and 9 months | Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome) |
| Executive function (correct responses) | Change from baseline at 5 months and 9 months | Simon Task: score (range 0-100, higher score indicates better outcome) |
| Psychological stress of the caregiver | Change from baseline at 5 months and 9 months | Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome) |
| Electroencephalography (EEG) | Change from baseline at 5 months and 9 months | Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks |
| Structural magnetic resonance imaging (sMRI): MPRAGE sequence | Change from baseline at 5 months and 9 months | Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions |
| Structural magnetic resonance imaging (sMRI): DTI sequence | Change from baseline at 5 months and 9 months | Structural connectivity of intra- and interhemispheric white matter tracts |
| Functional magnetic resonance imaging (fMRI): resting-state | Change from baseline at 5 months and 9 months | resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks |
| Functional magnetic resonance imaging (fMRI): singing-related activity | Change from baseline at 5 months and 9 months | task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs |
| Caregiver burden | Change from baseline at 5 months and 9 months | Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome) |
| Executive function (reaction times) | Change from baseline at 5 months and 9 months | Simon Task: reaction time mean (ms) |
| Attention (correct responses) | Change from baseline at 5 months and 9 months | Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome) |
| Attention (reaction times) | Change from baseline at 5 months and 9 months | Flexible Attention Test (FAT): reaction time mean (ms) |
| Working memory | Change from baseline at 5 months and 9 months | Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome) |
| Verbal memory | Change from baseline at 5 months and 9 months | Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome) |
| Verbal learning | Change from baseline at 5 months and 9 months | Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome) |
Countries
Finland
Outcome results
None listed