Music therapy protocol to support bulbar and respiratory functions in patients with early and mid-stage amyotrophic lateral sclerosis: a feasibility study

Background and aims. Respiratory failure, malnutrition, aspiration pneumonia and dehydration contribute to mortality in ALS. Loss of natural communication impacts quality of life. Previous studies demonstrate that music therapy exercises are effective for rehabilitation of patients with neurological conditions. The aims of the study were to investigate the feasibility of conducting home-based research, measuring the effects of a new music therapy protocol on bulbar and respiratory function in persons with ALS. It is the first biomedical music therapy research to do this and the first study of any kind to systematically look at supporting bulbar and respiratory functions in ALS. Methodology. Eight newly diagnosed patients were recruited. The music therapy protocol was delivered to all participants twice weekly for 6 weeks. The study duration was 16 weeks, with run-in, treatment and wash-out phases. Feasibility data (recruitment, retention, adherence, tolerability, self-motivation, personal impressions) were collected. Bulbar and respiratory changes were objectively measured. Results. High recruitment rate (100%), retention rate (87.5%) and mean adherence to treatment (95.4%) provide evidence for feasibility of the study protocol. The treatment was tolerated well. Mean adherence to the suggested independent exercise routine was 53%. The outcome measurements to evaluate the therapy-induced change in bulbar and respiratory functions were defined. Findings suggest that the protocol is safe to use in early and mid-stage ALS and that music therapy was beneficial for the participants’ bulbar and respiratory functions. Mean trends suggesting that these functions were sustained or improved during the treatment period were observed for most outcome parameters: Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Peak Expiratory Flow, Center for Neurologic Study – Bulbar Function Scale speech and swallowing subscales, Maximum Phonation Time, Maximum Repetition Rate – Alternating, Maximum Repetition Rate – Sequential, Jitter, Shimmer, NHR, Speaking rate, Speech-pause ratio, Pause frequency, Hypernasality level, Time-to Laryngeal Vestibule Closure, Maximum Pharyngeal Constriction Area, Peak Position of the Hyoid Bone, Total Pharyngeal Residue C24area. Conclusion. The suggested design and protocol are feasible for a larger study, with some modifications, including: aerodynamic measure of nasalance, abbreviated voice sampling and psychological screening.