Choir Singing in Aphasia Rehabilitation

NCT ID: NCT03501797

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-03-15

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.

Conditions

Stroke; Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early singing intervention (AB)

Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.

Group Type: EXPERIMENTAL

Singing-based rehabilitation

Intervention Type: BEHAVIORAL

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 care

Intervention Type: OTHER

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

Late singing intervention (BA)

Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.

Group Type: EXPERIMENTAL

Singing-based rehabilitation

Intervention Type: BEHAVIORAL

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 care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role: collaborator

Helsinki-Uusimaa Aphasia and Stroke Association

UNKNOWN

Sponsor Role: collaborator

Finnish Brain Association

UNKNOWN

Sponsor Role: collaborator

Outloud Ltd

UNKNOWN

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Teppo Sarkamo

Academy of Finland Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teppo Särkämö, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit

Helsinki, , Finland

Helsinki-Uusimaa Aphasia and Stroke Association

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 40738917 (View on PubMed)

Siponkoski 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.

Reference Type: DERIVED

PMID: 36687394 (View on PubMed)

Other Identifiers

306625

Identifier Type: -

Identifier Source: org_study_id