Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
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ClinicalTrials.gov Identifier: NCT03604822 |
Recruitment Status : Unknown
Verified July 2018 by Alisa Apreleva, Anglia Ruskin University.
Recruitment status was: Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
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 |
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Experimental: Music therapy protocol
Each participant received 12 home-based music therapy treatment sessions over 6-week time period.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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).
- 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).
- 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
- 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
- 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
- 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
- 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

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

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
Russian Federation | |
ALS Moscow Centre | |
Moscow, Russian Federation | |
United Kingdom | |
Cambridge Institute for Music Therapy Research (CIMTR) | |
Cambridge, Cambridgeshire, United Kingdom |
Principal Investigator: | Alisa Apreleva, MA | Anglia Ruskin University |
Publications:
Responsible Party: | Alisa Apreleva, Principal Investigator, Anglia Ruskin University |
ClinicalTrials.gov Identifier: | NCT03604822 |
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 |
Music Therapy Neurologic Music Therapy Rehabilitation Amyotrophic Lateral Sclerosis ALS |
Pneumonia Dyspnea Pneumonia, Aspiration Motor Neuron Disease Amyotrophic Lateral Sclerosis Dysarthria Sclerosis 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 Neurologic Manifestations Articulation Disorders Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations |