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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03501797
Other study ID # 306625
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date March 15, 2020

Study information

Verified date August 2022
Source University of Helsinki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 15, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Singing-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.
Other:
Standard 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

Locations

Country Name City State
Finland Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit Helsinki
Finland Helsinki-Uusimaa Aphasia and Stroke Association Helsinki

Sponsors (9)

Lead Sponsor Collaborator
University of Helsinki Finnish Brain Association, Harvard Medical School (HMS and HSDM), Helsinki University Central Hospital, Helsinki-Uusimaa Aphasia and Stroke Association, Hospital District of Helsinki and Uusimaa, Outloud Ltd, University of Barcelona, University of Melbourne

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Connected speech informativeness Percentage of correct information units (CIUs) produced in a picture description task Change from baseline at 5 months and 9 months
Primary 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
Primary 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
Primary 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
Primary 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 Executive function (correct responses) Simon Task: score (range 0-100, higher score indicates better outcome) Change from baseline at 5 months and 9 months
Secondary Executive function (reaction times) Simon Task: reaction time mean (ms) Change from baseline at 5 months and 9 months
Secondary 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
Secondary Attention (reaction times) Flexible Attention Test (FAT): reaction time mean (ms) Change from baseline at 5 months and 9 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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