Clinical trial NCT03501797: Choir Singing in Aphasia Rehabilitation
Official title: Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Hospital District of Helsinki and Uusimaa
name: Helsinki-Uusimaa Aphasia and Stroke Association
name: Finnish Brain Association
name: Outloud Ltd
name: University of Barcelona
name: University of Melbourne
name: Harvard Medical School (HMS and HSDM)
First posted: 2018-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Communication ability
timeFrame: Change from baseline at 5 months and 9 months
measure: Spontaneous speech production
timeFrame: Change from baseline at 5 months and 9 months
measure: Connected speech informativeness
timeFrame: Change from baseline at 5 months and 9 months
measure: Repetition of words and sentences
timeFrame: Change from baseline at 5 months and 9 months
measure: Verbal agility
timeFrame: Change from baseline at 5 months and 9 months
measure: Naming and word finding
timeFrame: Change from baseline at 5 months and 9 months
measure: Verbal comprehension
timeFrame: Change from baseline at 5 months and 9 months
Secondary outcomes:
measure: Executive function (correct responses)
timeFrame: Change from baseline at 5 months and 9 months
measure: Executive function (reaction times)
timeFrame: Change from baseline at 5 months and 9 months
measure: Attention (correct responses)
timeFrame: Change from baseline at 5 months and 9 months
measure: Attention (reaction times)
timeFrame: Change from baseline at 5 months and 9 months
measure: Working memory
timeFrame: Change from baseline at 5 months and 9 months
measure: Verbal memory
timeFrame: Change from baseline at 5 months and 9 months
measure: Verbal learning
timeFrame: Change from baseline at 5 months and 9 months
measure: Singing ability
timeFrame: Change from baseline at 5 months and 9 months
measure: Music perception
timeFrame: Change from baseline at 5 months and 9 months
measure: Functional stroke recovery
timeFrame: Change from baseline at 5 months and 9 months
measure: Depression
timeFrame: Change from baseline at 5 months and 9 months
measure: Mood
timeFrame: Change from baseline at 5 months and 9 months
measure: Social interaction
timeFrame: Change from baseline at 5 months and 9 months
measure: Caregiver burden
timeFrame: Change from baseline at 5 months and 9 months
measure: Psychological stress of the caregiver
timeFrame: Change from baseline at 5 months and 9 months
measure: Electroencephalography (EEG)
timeFrame: Change from baseline at 5 months and 9 months
measure: Structural magnetic resonance imaging (sMRI): MPRAGE sequence
timeFrame: Change from baseline at 5 months and 9 months
measure: Structural magnetic resonance imaging (sMRI): DTI sequence
timeFrame: Change from baseline at 5 months and 9 months
measure: Functional magnetic resonance imaging (fMRI): resting-state
timeFrame: Change from baseline at 5 months and 9 months
measure: Functional magnetic resonance imaging (fMRI): singing-related activity
timeFrame: Change from baseline at 5 months and 9 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
city: Helsinki
country: Finland
facility: Helsinki-Uusimaa Aphasia and Stroke Association
Study officials:
affiliation: University of Helsinki
name: Teppo Särkämö, PhD
role: PRINCIPAL_INVESTIGATOR
References: