An at-home music therapy program aimed at improving speech, swallowing, and respiration in people with amyotrophic lateral sclerosis (ALS) was well-tolerated and feasible, according to a small pilot study.
While the pilot study (NCT03604822) was not designed to test the program’s effectiveness, collected data suggest that the music therapy helped with breathing and in easing other bulbar symptoms, or those involving the face and neck.
“This is the first biomedical [music therapy] study involving [people with ALS] and the first study of any kind to systematically look at supporting bulbar and respiratory functions in ALS,” the researchers wrote, adding that a larger study into the program’s effectiveness is warranted.
The study, “Home-Based Music Therapy to Support Bulbar and Respiratory Functions of Persons with Early and Mid-Stage Amyotrophic Lateral Sclerosis — Protocol and Results from a Feasibility Study,” was published in Brain Sciences.
While the muscles controlling the limbs are often the first affected in ALS (called limb-onset ALS), most patients at some point experience bulbar symptoms, leading to difficulties with speaking, swallowing, and breathing.
Music therapy is thought to stimulate the brain and have therapeutic effects on cognition, sensory problems, psychological distress, and motor dysfunction, but its potential with the bulbar and respiratory symptoms of ALS is not yet known.
A team of researchers in Russia and the U.K. developed, reportedly the first time, a musical therapy intervention program aimed at improving bulbar and respiratory strength in people with early- to mid-stage ALS. They evaluated its safety and tolerability in a pilot study.
The 16-week program included a six week pre-therapy (control) phase, six weeks of music therapy, and then a four-week washout period for further evaluation.
Roughly hour-long treatment sessions were delivered to patients in their homes twice weekly by a certified music therapist, and consisted of individually tailored music-based breathing exercises, gentle stretching, muscle relaxation, and singing. Participants were also encouraged, but not required, to engage in an “independent study” of breathing, relaxation, and voice skills using a recorded guide and printed instructions to promote “healthy voice use habits in daily life.”
Eight newly diagnosed patients — six women and two men with a mean age of 58.1 — were recruited to participate in the feasibility study at the ALS Centre Moscow. Seven had limb-onset ALS and one had bulbar onset.
The study’s main goal was to determine if the therapy program was feasible, well-tolerated, and safe.
It was determined to be generally feasible, with seven of eight patients completing the study. Adherence to the therapy program was 95.4%, and adherence to the suggested independent study was 53%. Patients cited reasons such as feeling unwell, being busy, and being tired for not performing the independent study.
The program was also generally well-tolerated, with non-significant trends toward improvements in self-reported ease of speech and respiration observed among the seven people who completed the program.
All of these participants reported that the therapy was pleasurable and easy to perform, with most feeling that it benefitted their speech, respiration, and communication abilities, but not swallowing.
Of six caregivers who completed a questionnaire, most thought that the therapy improved or sustained a patient’s bulbar or respiratory functions. Some also felt that the communication with the music therapist had a positive psychological impact on both them and the family member with ALS.
The trial’s main researcher, the music therapist, supported the therapy being safe when implemented with modifications for each individual patient.
Secondary study outcome measures included assessing the feasibility of a battery of biomedical tests to determine bulbar and respiratory function before, during, and after the program. Generally, these tests appeared to be a feasible and reliable way of assessing patients’ bulbar symptoms and respiratory abilities.
Due to its small size, the study was not designed to test the efficacy of the music therapy. Nonetheless, trends toward sustained or improved function across 32 respiratory, speech, and swallowing domains were observed during the therapy phase compared with measures before its start. These gains tended to deteriorate during the washout phase, the researchers noted.
Findings overall support the use of music therapy in ALS patients. They “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,” the researchers wrote. However, “the sample size of this feasibility study is very small,” they noted, and “no general assumptions should be drawn.”
Rather, “a study with the main goal of understanding the effect of the described [music therapy] protocol on bulbar and respiratory dysfunction in ALS has to be designed with a larger cohort,” the scientists wrote.
Minor modifications to the protocol, including the addition of a mental health assessment, should be included in future studies, the team added.