StrokeNCT03501797
Choir Singing in Aphasia Rehabilitation
A study testing Singing-based rehabilitation in people with Stroke and Aphasia, run by University of Helsinki at 2 sites in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Singing-based rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Jan 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
Helsinki
Helsinki-Uusimaa Aphasia and Stroke Association
Helsinki
About this study
Official title: Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
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.
Read the 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.
- Being tested
- Singing-based rehabilitation, Standard care
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing-based rehabilitationBehavioural
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.
Standard careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Early singing intervention (AB) | Experimental | Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only. Receives: Behavioral: Singing-based rehabilitation; Other: Standard care |
| Late singing intervention (BA) | Experimental | Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC. Receives: Behavioral: Singing-based rehabilitation; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication ability
Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)
Measured: 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)
Measured: Change from baseline at 5 months and 9 months
Connected speech informativeness
Percentage of correct information units (CIUs) produced in a picture description task
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline at 5 months and 9 months
Secondary outcomes (20)
Executive function (correct responses)
Simon Task: score (range 0-100, higher score indicates better outcome)
Measured: Change from baseline at 5 months and 9 months
Executive function (reaction times)
Simon Task: reaction time mean (ms)
Measured: 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)
Measured: Change from baseline at 5 months and 9 months
Attention (reaction times)
Flexible Attention Test (FAT): reaction time mean (ms)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline at 5 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jan 2018
- Primary completion31 Jan 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Principal investigator, Teppo Sarkamo, University of Helsinki
- Investigators
- Teppo Särkämö, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501797
- Sponsor's protocol ID
- 306625
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2018
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Molina N, Pitkaniemi A, Siponkoski ST, Moisseinen N, Kuusela L, Laitinen S, Sarkamo ER, Pekkola J, Melkas S, Schlaug G, Kleber B, Sihvonen AJ, Sarkamo T. Functional neuroplasticity in chronic post-stroke aphasia following a singing intervention in a cross-over randomised trial. Sci Rep. 2025 Jul 29;15(1):27639. doi: 10.1038/s41598-025-11288-0.
PubMed 40738917Siponkoski ST, Pitkaniemi A, Laitinen S, Sarkamo ER, Pentikainen E, Eloranta H, Tuomiranta L, Melkas S, Schlaug G, Sihvonen AJ, Sarkamo T. Efficacy of a multicomponent singing intervention on communication and psychosocial functioning in chronic aphasia: a randomized controlled crossover trial. Brain Commun. 2022 Dec 27;5(1):fcac337. doi: 10.1093/braincomms/fcac337. eCollection 2023.
PubMed 36687394
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
- ClinicalTrials.gov ID
- NCT03501797
- Acronym / sponsor ID
- 306625
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early singing intervention (AB) | Experimental | Behavioral: Singing-based rehabilitation, Other: Standard careParticipants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only. |
| Late singing intervention (BA) | Experimental | Behavioral: Singing-based rehabilitation, Other: Standard careParticipants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singing-based rehabilitationThe 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. | Behavioural | Early singing intervention (AB), Late singing intervention (BA) |
| Standard careStandard 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 | Other | Early singing intervention (AB), Late singing intervention (BA) |
Primary outcome
Communication ability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
20 secondary outcomes
Executive function (correct responses)
Time frame: Change from baseline at 5 months and 9 months
Executive function (reaction times)
Time frame: Change from baseline at 5 months and 9 months
Attention (correct responses)
Time frame: Change from baseline at 5 months and 9 months
Attention (reaction times)
Time frame: Change from baseline at 5 months and 9 months
Working memory
Time frame: Change from baseline at 5 months and 9 months
Verbal memory
Time frame: Change from baseline at 5 months and 9 months
Verbal learning
Time frame: Change from baseline at 5 months and 9 months
Singing ability
Time frame: Change from baseline at 5 months and 9 months
Music perception
Time frame: Change from baseline at 5 months and 9 months
Functional stroke recovery
Time frame: Change from baseline at 5 months and 9 months
Depression
Time frame: Change from baseline at 5 months and 9 months
Mood
Time frame: Change from baseline at 5 months and 9 months
Social interaction
Time frame: Change from baseline at 5 months and 9 months
Caregiver burden
Time frame: Change from baseline at 5 months and 9 months
Psychological stress of the caregiver
Time frame: Change from baseline at 5 months and 9 months
Electroencephalography (EEG)
Time frame: Change from baseline at 5 months and 9 months
Structural magnetic resonance imaging (sMRI): MPRAGE sequence
Time frame: Change from baseline at 5 months and 9 months
Structural magnetic resonance imaging (sMRI): DTI sequence
Time frame: Change from baseline at 5 months and 9 months
Functional magnetic resonance imaging (fMRI): resting-state
Time frame: Change from baseline at 5 months and 9 months
Functional magnetic resonance imaging (fMRI): singing-related activity
Time frame: Change from baseline at 5 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 40738917Martinez-Molina N, Pitkaniemi A, Siponkoski ST, Moisseinen N, Kuusela L, Laitinen S, Sarkamo ER, Pekkola J, Melkas S, Schlaug G, Kleber B, Sihvonen AJ, Sarkamo T. Functional neuroplasticity in chronic post-stroke aphasia following a singing intervention in a cross-over randomised trial. Sci Rep. 2025 Jul 29;15(1):27639. doi: 10.1038/s41598-025-11288-0.
- Derived from this study: PubMed 36687394Siponkoski ST, Pitkaniemi A, Laitinen S, Sarkamo ER, Pentikainen E, Eloranta H, Tuomiranta L, Melkas S, Schlaug G, Sihvonen AJ, Sarkamo T. Efficacy of a multicomponent singing intervention on communication and psychosocial functioning in chronic aphasia: a randomized controlled crossover trial. Brain Commun. 2022 Dec 27;5(1):fcac337. doi: 10.1093/braincomms/fcac337. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teppo Särkämö, PhD principal investigator
University of Helsinki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing-based rehabilitation in people with Stroke and Aphasia, run by University of Helsinki at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication ability (time frame: Change from baseline at 5 months and 9 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.