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Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS

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ClinicalTrials.gov Identifier: NCT03604822
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
ALS Centre Moscow
Information provided by (Responsible Party):
Alisa Apreleva, Anglia Ruskin University

Brief Summary:
This study evaluates potential of music therapy treatment to support breathing, speech, swallow and cough of persons with amyotrophic lateral sclerosis (ALS). Music therapy is the clinical use of music and its elements to enhance human health and wellbeing. Application of music therapy principles in neurorehabilitation allow to treat cognitive, sensory, and motor dysfunctions.

Condition or disease Intervention/treatment Phase
Motor Neuron Disease, Amyotrophic Lateral Sclerosis ALS (Amyotrophic Lateral Sclerosis) Dysarthria, Flaccid Dysarthria, Spastic Dysarthria, Mixed Dysphagia Dyspnea Aspiration Pneumonia Hypernasality Breathlessness Procedure: Music therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-subject design (Repeated measures)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Measuring the Effects of a Music Therapy Protocol on Respiratory and Bulbar Functions of Patients With Early and Mid-stage Amyotrophic Lateral Sclerosis: Mixed Methods Single Case Study Series
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : January 1, 2020


Arm Intervention/treatment
Experimental: Music therapy protocol
Each participant received 12 home-based music therapy treatment sessions over 6-week time period.
Procedure: Music therapy
ALS-specific, individualized MT protocol was delivered to study participants in their homes twice weekly for the duration of six weeks by the researcher. Facilitating music structures were composed by the researcher to support cueing, timing and intensity of breathing and vocalization exercises. These structures were regularly modified to suit the unique capabilities, current individual demands and progress of each participant. One familiar song, selected by the participant, was used for each participant in therapeutic singing exercise closing each session. Individualized exercises sets for independent practice were provided at session 3 to each participants. ALS-specific voice health guidelines were provided for participants prior to start of the treatment.




Primary Outcome Measures :
  1. Change of Forced Vital Capacity (FVC) from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    FVC is a standard spirometry test which measures the volume of air that can forcibly be blown out after full inspiration.

  2. Change of Maximal Inspiratory Pressure (MIP) from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    MIP is the inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength.

  3. Change of Maximal Expiratory Pressure (MEP) from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    MIP is a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece.

  4. Change of Peak Cough Flow (PCF) from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    PCF is a measure of cough effectiveness, portable peak flow meter was used.

  5. Change of Center for Neurologic Study Bulbar Function Scale (CNS-BFS) Swallowing subscore from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    The Center for Neurologic Study Bulbar Function Scale (CNS-BFS) consists of three domains (swallowing, speech, and salivation), each of which is assessed with a 7-item, self report questionnaire. Each question is scored from "1" (does not apply) to "5" (applies most of the time). Swallowing domain subscore can range from "7" (best outcome) to "35" (worst outcome).

  6. Change of Center for Neurologic Study Bulbar Function Scale (CNS-BFS) Speech subscore from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    The Center for Neurologic Study Bulbar Function Scale (CNS-BFS) consists of three domains (swallowing, speech, and salivation), each of which is assessed with a 7-item, self report questionnaire. Each question is scored from "1" (does not apply) to "5" (applies most of the time). Speech domain subscore can range from "7" (best outcome) to "35" (worst outcome).

  7. Change in video fluoroscopic swallowing study (VFSS) results from baseline at Week 6, Week 12 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    VFSS is an x-ray-based method of evaluating a person's swallowing ability.

  8. Change in acoustic assessment parameters of recorded voice from baseline at Week 6, Week 12, Week 16 [ Time Frame: Throughout the field phase of the study (16 weeks) ]
    Machine-analyzed set of structured voice samples.

  9. Change in Visual Analogue Scale for current perceived ease of respiration from pre-treatment to post-treatment [ Time Frame: Throughout the therapy phase (6 weeks) ]
    Visual Analogue Scale (VAS) for current perceived ease of respiration is a one question 10-point scale administered at the beginning and at the end of every music therapy session to assess short-term change in current perceived ease of respiration. The outcome can range from "1" (very difficult) to "10" (very easy).

  10. Change of Visual Analogue Scale for current perceived ease of speech from pre-treatment to post-treatment [ Time Frame: Throughout the therapy phase (6 weeks) ]
    Visual Analogue Scale (VAS) for current perceived ease of speech is a one question 10-point scale administered at the beginning and at the end of every music therapy session to assess short-term change in current perceived ease of speech. The outcome can range from "1" (very difficult) to "10" (very easy).

  11. Phenomenological analysis of participant semi-structured interviews pre-treatment [ Time Frame: Week 5 ]
    Analysis of participant's answers to open questions in regards to expectations for music therapy treatment

  12. Phenomenological analysis of caregiver semi-structured interview pre-treatment [ Time Frame: Week 5 ]
    Analysis of main caregiver's answers to open questions in regards to expectations for music therapy treatment

  13. Phenomenological analysis of treatment sessions documentation [ Time Frame: Throughout the therapy phase (6 weeks) ]
    Analysis of narrative accounts of music therapy sessions submitted by the therapist

  14. Phenomenological analysis of participant semi-structured interviews post-treatment [ Time Frame: Week 13 ]
    Analysis of participant's answers to open questions in regards to impressions of music therapy treatment

  15. Phenomenological analysis of caregiver semi-structured interview post-treatment [ Time Frame: Week 13 ]
    Analysis of main caregiver's answers to open questions in regards to impressions of music therapy treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients at ALS Centre Moscow (consecutive sampling)
  • Diagnosis of probable or definite ALS by the revised El Escorial criteria confirmed by neurologist at ALS Moscow Centre prior to screening for enrollment.
  • Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) bulbar subscore ≥ 9, but ≤ 11, where bulbar score=the sum of ALSFRS-R questions 1-3 (maximum score of 12)
  • Forced vital capacity (FVC) greater than 60%
  • Unimpaired cognition as evidenced by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) cut-off scores adjusted for age and education
  • Able to consent to treatment
  • Native speakers of Russian

Exclusion Criteria:

  • Tracheostomy or mechanical ventilation
  • Diaphragmatic pacer
  • Significant concurrent respiratory disease
  • Allergies to barium
  • Receiving any other experimental treatment for dysarthria, dysphagia, dystussia and dyspnoea for the duration of the study
  • Receiving any other music therapy treatment for the duration of the study

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): NCT03604822


Locations
Russian Federation
ALS Moscow Centre
Moscow, Russian Federation
United Kingdom
Cambridge Institute for Music Therapy Research (CIMTR)
Cambridge, Cambridgeshire, United Kingdom
Sponsors and Collaborators
Alisa Apreleva
ALS Centre Moscow
Investigators
Principal Investigator: Alisa Apreleva, MA Anglia Ruskin University

Additional Information:
Publications:
Cohen, N. S. 1992. The effect of singing instruction on the speech production of neurologically impaired persons. Journal of Music Therapy, 29(87-103)
Davies, R., Baker, F. A., Tamplin, J., Bajo, E., Bolger, K., Sheers, N. & Berlowitz, D. 2016. Music-assisted relaxation during transition to non-invasive ventilation in people with motor neuron disease: A qualitative case series. British Journal of Music Therapy, 30(2), pp 74-82.
Forrest, L. Using Music Therapy in the Symptom Management of Patients with Motor Neurone Disease. 10th World congress on music therapy, 2002 Oxford, UK.
K. Hanson, E., M. Yorkston, K. & Britton, D. 2011. Dysarthria in amyotrophic lateral sclerosis: a systematic review of characteristics, speech treatment, and augmentative and alternative communication options.(Report). Journal of Medical Speech - Language Pathology, 19(3), pp 12
Kondo, K. 2017. Music therapy for patients with amyotrophic lateral sclerosis receiving home mechanical ventilation. Journal of the Neurological Sciences, 381(561 - 756)
Lings, J. 2014. From 'can't' to 'can' : an exploration of the experience of improvisation with a client with Motor Neurone Disease Counterpoints: Music Therapy Practice in the 21st Century, First BAMT conference. Birmingham, UK
Magee, W. 1998. Singing my life, playing my self: investigating the use of familiar pre-composed music and unfamiliar improvised music in clinical music therapy with individuals with chronic neurological illness. ProQuest Dissertations Publishing
Nishio, M. & Niimi, S. 2000. Changes over Time in Dysarthric Patients with Amyotrophic Lateral Sclerosis (ALS): A Study of Changes in Speaking Rate and Maximum Repetition Rate (MRR). Clinical Linguistics & Phonetics, 14(7), pp 485-497
Petering, H. 2005. Fostering hope through music therapy with people with Motor Neurone Disease 11th World Congress of Music Therapy, Brisbane, Australia
Pietkiewicz, I. & Smith, J. A. 2014. A practical guide to using Interpretative Phenomenological Analysis in qualitative research psychology. Czasopismo Psychologiczne - Psychological Journal, 20(1), pp 7 - 14
Schmid, W. 2016. MusicALS: home-based music therapy for individuals with amyotrophic lateral sclerosis (ALS) and their caring families. Nord. J. Music Ther., 25(sup1), pp 66-66
Tamplin, J. & Grocke, D. 2008. A Music Therapy Treatment Protocol for Acquired Dysarthria Rehabilitation. Music Therapy Perspectives, 26(1), pp 23-29
Thaut, M. & H©œmberg, V. 2016. Handbook of neurologic music therapy: Oxford : Oxford University Press
Touré‐Tillery, M. & Fishbach, A. 2014. How to Measure Motivation: A Guide for the Experimental Social Psychologist. Social and Personality Psychology Compass, 8(7), pp 328-341

Responsible Party: Alisa Apreleva, Principal Investigator, Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT03604822     History of Changes
Other Study ID Numbers: ALSMT01
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pseudonymized individual participant data for all outcome measures will be made available.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Within 6 months of study completion, indefinitely.
Access Criteria: Contact sponsor-investigator for data access.
URL: http://alsmusictherapy.org

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

Keywords provided by Alisa Apreleva, Anglia Ruskin University:
Music Therapy
Neurologic Music Therapy
Rehabilitation
Amyotrophic Lateral Sclerosis
ALS

Additional relevant MeSH terms:
Sclerosis
Pneumonia
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Dyspnea
Dysarthria
Pneumonia, Aspiration
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations