Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS

NCT03604822 | Unknown DMC

• 1 other identifier: ALSMT01
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 2

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.

Conditions

Motor Neuron Disease, Amyotrophic Lateral Sclerosis; ALS (Amyotrophic Lateral Sclerosis); Dysarthria, Flaccid; Dysarthria, Spastic; Dysarthria, Mixed; Dysphagia; Dyspnea; Aspiration Pneumonia; Hypernasality; Breathlessness

Keywords

Music Therapy; Neurologic Music Therapy; Rehabilitation; Amyotrophic Lateral Sclerosis; ALS

Outcome Measures

Primary Outcomes (15)

• Change of Forced Vital Capacity (FVC) from baseline at Week 6, Week 12, Week 16

  FVC is a standard spirometry test which measures the volume of air that can forcibly be blown out after full inspiration.

  Throughout the field phase of the study (16 weeks)

• Change of Maximal Inspiratory Pressure (MIP) from baseline at Week 6, Week 12, Week 16

  MIP is the inspiratory pressure generated against a completely occluded airway; used to evaluate inspiratory respiratory muscle strength.

  Throughout the field phase of the study (16 weeks)

• Change of Maximal Expiratory Pressure (MEP) from baseline at Week 6, Week 12, Week 16

  MIP is a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece.

  Throughout the field phase of the study (16 weeks)

• Change of Peak Cough Flow (PCF) from baseline at Week 6, Week 12, Week 16

  PCF is a measure of cough effectiveness, portable peak flow meter was used.

  Throughout the field phase of the study (16 weeks)

• Change of Center for Neurologic Study Bulbar Function Scale (CNS-BFS) Swallowing subscore from baseline at Week 6, Week 12, Week 16

  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).

  Throughout the field phase of the study (16 weeks)

• Change of Center for Neurologic Study Bulbar Function Scale (CNS-BFS) Speech subscore from baseline at Week 6, Week 12, Week 16

  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).

  Throughout the field phase of the study (16 weeks)

• Change in video fluoroscopic swallowing study (VFSS) results from baseline at Week 6, Week 12

  VFSS is an x-ray-based method of evaluating a person's swallowing ability.

  Throughout the field phase of the study (16 weeks)

• Change in acoustic assessment parameters of recorded voice from baseline at Week 6, Week 12, Week 16

  Machine-analyzed set of structured voice samples.

  Throughout the field phase of the study (16 weeks)

• Change in Visual Analogue Scale for current perceived ease of respiration from pre-treatment to post-treatment

  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).

  Throughout the therapy phase (6 weeks)

• Change of Visual Analogue Scale for current perceived ease of speech from pre-treatment to post-treatment

  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).

  Throughout the therapy phase (6 weeks)

• Phenomenological analysis of participant semi-structured interviews pre-treatment

  Analysis of participant's answers to open questions in regards to expectations for music therapy treatment

  Week 5

• Phenomenological analysis of caregiver semi-structured interview pre-treatment

  Analysis of main caregiver's answers to open questions in regards to expectations for music therapy treatment

  Week 5

• Phenomenological analysis of treatment sessions documentation

  Analysis of narrative accounts of music therapy sessions submitted by the therapist

  Throughout the therapy phase (6 weeks)

• Phenomenological analysis of participant semi-structured interviews post-treatment

  Analysis of participant's answers to open questions in regards to impressions of music therapy treatment

  Week 13

• Phenomenological analysis of caregiver semi-structured interview post-treatment

  Analysis of main caregiver's answers to open questions in regards to impressions of music therapy treatment

  Week 13

Study Arms (1)

Music therapy protocol

EXPERIMENTAL

Each participant received 12 home-based music therapy treatment sessions over 6-week time period.

Procedure: Music therapy

Interventions

Music therapy PROCEDURE

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.

Music therapy protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alisa Apreleva: lead
• ALS Centre Moscow: collaborator

Study Sites (2)

ALS Moscow Centre

Moscow, Russia

Location

Cambridge Institute for Music Therapy Research (CIMTR)

Cambridge, Cambridgeshire, United Kingdom

Location

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  PMID: 21372794 BACKGROUND

Related Links

• Music therapy for ALS research blog
• Cambridge Institute for Music Therapy Research (CIMTR), Anglia Ruskin University
• ALS Centre Moscow

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Dysarthria; Deglutition Disorders; Dyspnea; Pneumonia, Aspiration

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alisa Apreleva, MA

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-subject design (Repeated measures)

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 30, 2018
• Study Start: September 27, 2017
• Primary Completion: July 31, 2018
• Study Completion: January 1, 2020
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Within 6 months of study completion, indefinitely.
• Access Criteria: Contact sponsor-investigator for data access.

Locations

GB (1); RU (1)