Choir Singing in Aphasia Rehabilitation

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia

Conditions
-----------------
Stroke, Aphasia

Intervention / Treatment
-----------------
* Behavioral: Singing-based rehabilitation
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early singing intervention (AB)<br>Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only. | Behavioral: Singing-based rehabilitation<br>* 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.<br>Other: Standard care<br>* 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<br>|
| Experimental: Late singing intervention (BA)<br>Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC. | Behavioral: Singing-based rehabilitation<br>* 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.<br>Other: Standard care<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication ability | Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Spontaneous speech production | Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Connected speech informativeness | Percentage of correct information units (CIUs) produced in a picture description task | Change from baseline at 5 months and 9 months | 
| Repetition of words and sentences | Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Verbal agility | Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Naming and word finding | Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Verbal comprehension | Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function (correct responses) | Simon Task: score (range 0-100, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Executive function (reaction times) | Simon Task: reaction time mean (ms) | Change from baseline at 5 months and 9 months | 
| Attention (correct responses) | Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Attention (reaction times) | Flexible Attention Test (FAT): reaction time mean (ms) | Change from baseline at 5 months and 9 months | 
| Working memory | Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Verbal memory | Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Verbal learning | Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Singing ability | Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software | Change from baseline at 5 months and 9 months | 
| Music perception | Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Functional stroke recovery | Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Depression | Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Mood | Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Social interaction | Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Caregiver burden | Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Psychological stress of the caregiver | Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome) | Change from baseline at 5 months and 9 months | 
| Electroencephalography (EEG) | Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks | Change from baseline at 5 months and 9 months | 
| Structural magnetic resonance imaging (sMRI): MPRAGE sequence | Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions | Change from baseline at 5 months and 9 months | 
| Structural magnetic resonance imaging (sMRI): DTI sequence | Structural connectivity of intra- and interhemispheric white matter tracts | Change from baseline at 5 months and 9 months | 
| Functional magnetic resonance imaging (fMRI): resting-state | resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks | Change from baseline at 5 months and 9 months | 
| Functional magnetic resonance imaging (fMRI): singing-related activity | task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs | Change from baseline at 5 months and 9 months |