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Choir Singing in Aphasia Rehabilitation

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ClinicalTrials.gov Identifier: NCT03501797
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
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
Information provided by (Responsible Party):
Teppo Sarkamo, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Behavioral: Singing-based rehabilitation Other: Standard care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early singing intervention (AB)
Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.
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

Experimental: Late singing intervention (BA)
Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.
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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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)


Secondary Outcome Measures :
  1. Executive function (correct responses) [ Time Frame: Change from baseline at 5 months and 9 months ]
    Simon Task: score (range 0-100, higher score indicates better outcome)

  2. Executive function (reaction times) [ Time Frame: Change from baseline at 5 months and 9 months ]
    Simon Task: reaction time mean (ms)

  3. Attention (correct responses) [ Time Frame: Change from baseline at 5 months and 9 months ]
    Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome)

  4. Attention (reaction times) [ Time Frame: Change from baseline at 5 months and 9 months ]
    Flexible Attention Test (FAT): reaction time mean (ms)

  5. Working memory [ Time Frame: Change from baseline at 5 months and 9 months ]
    Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome)

  6. Verbal memory [ Time Frame: Change from baseline at 5 months and 9 months ]
    Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome)

  7. Verbal learning [ Time Frame: Change from baseline at 5 months and 9 months ]
    Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome)

  8. Singing ability [ Time Frame: Change from baseline at 5 months and 9 months ]
    Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software

  9. Music perception [ Time Frame: Change from baseline at 5 months and 9 months ]
    Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome)

  10. Functional stroke recovery [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome)

  11. Depression [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome)

  12. Mood [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome)

  13. Social interaction [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome)

  14. Caregiver burden [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome)

  15. Psychological stress of the caregiver [ Time Frame: Change from baseline at 5 months and 9 months ]
    Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome)

  16. Electroencephalography (EEG) [ Time Frame: Change from baseline at 5 months and 9 months ]
    Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks

  17. Structural magnetic resonance imaging (sMRI): MPRAGE sequence [ Time Frame: Change from baseline at 5 months and 9 months ]
    Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions

  18. Structural magnetic resonance imaging (sMRI): DTI sequence [ Time Frame: Change from baseline at 5 months and 9 months ]
    Structural connectivity of intra- and interhemispheric white matter tracts

  19. Functional magnetic resonance imaging (fMRI): resting-state [ Time Frame: Change from baseline at 5 months and 9 months ]
    resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks

  20. Functional magnetic resonance imaging (fMRI): singing-related activity [ Time Frame: Change from baseline at 5 months and 9 months ]
    task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501797


Contacts
Contact: Teppo Särkämö, PhD +358505399065 teppo.sarkamo@helsinki.fi

Locations
Finland
Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit Recruiting
Helsinki, Finland
Contact: Aarne Ylinen, PhD       aarne.ylinen@hus.fi   
Contact: Susanna Melkas, PhD       susanna.melkas@hus.fi   
Helsinki-Uusimaa Aphasia and Stroke Association Recruiting
Helsinki, Finland
Contact: Heidi Eloranta, MA       yhdistys@afasiakeskus.fi   
Sponsors and Collaborators
Helsinki University
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
Investigators
Principal Investigator: Teppo Särkämö, PhD Helsinki University

Responsible Party: Teppo Sarkamo, Academy of Finland Research Fellow, Helsinki University
ClinicalTrials.gov Identifier: NCT03501797     History of Changes
Other Study ID Numbers: 306625
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms