Choir Singing in Aphasia Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501797
• Other study ID #: 306625
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Aphasia
• Stroke

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