RecruitingRecruiting
Music-4-MS to Improve Cognition in People Living With Multiple Sclerosis: A Feasibility Study
NCT07759115 · University of Texas at Austin
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized Controlled Trial of Music-4-MS Compared to Music Listening to Improve Cognition in People Living With Multiple Sclerosis: A Feasibility Study
About this study
Multiple sclerosis (MS) affects more than 2.8 million people worldwide; its prevalence has increased in every region and nearly doubled in the U.S. since 2013. In many countries, MS is the main cause of nontraumatic disability in young adults. The course of MS is unpredictable, and common symptoms in persons with MS include impaired day-to-day activities such as walking, cognitive impairment, vision problems, paresthesia in the extremities, trouble sleeping, and chronic pain. Physical difficulties associated with MS contribute to secondary symptoms of depression, anxiety, and fatigue.
Cognitive impairment affects up to 70% of people with MS, and the incidence of early-onset dementia is 7 times higher than it is in adults without MS. Impairments like slowed processing, poor memory, and learning difficulties impact quality of life, social, and occupational functioning. Working memory deficits are associated with reduced connectivity between brain regions, especially the frontal and parietal lobes, during memory encoding, maintenance, and recall. Cognitive-based rehabilitation, however, can improve memory and learning as well as symptoms of depression and anxiety, which may reinforce cognition. Traditional approaches to cognitive rehabilitation use restorative (drill-and-practice) and compensatory (management) strategies. Yet most cognitive interventions for persons with MS are predominantly visual or speech-focused, which eliminates the possibility of stimulating multiple senses.
Music consists of complex, multidomain stimuli that engage a large bilateral network of temporal, frontal, parietal, cerebellar, limbic, and paralimbic brain areas associated with multiple parallel cognitive, verbal, motor, and emotional processes. Playing a musical instrument involves intricate coordination and communication between multiple sensory systems (visual, auditory, tactile) and motor functions. As individuals read and translate musical notes into physical actions, they simultaneously receive feedback from their auditory system. The ability to engage these systems and coordinate multiple domains may induce new cortical pathways fostering neuroplasticity. This rewiring in the brain created by repeated musical practice can create alternate pathways and structures to help those with MS compensate for deficits caused by demyelinating disease. Music interventions for other neurodegenerative conditions have been studied, but very few have been implemented for those with MS. A recent systematic review evaluated the impact of active (singing, dancing, instrument playing) and passive (listening) music interventions on psychosocial and neurological outcomes in individuals with MS. Of the 15 studies reviewed, none examined a music learning intervention and the impact on cognitive impairment-a critical gap to be addressed.
Our multi-disciplinary team has conducted a proof-of-concept study to evaluate an innovative ukulele training intervention, Music-4-MS, to address the gap in cognitive rehabilitation for persons with MS. Based on the feedback from participants in that study, our team of experts in human and music learning, music therapy, neuroscience, nursing, and cognitive rehabilitation optimized Music-4-MS. The primary goal of the present study is to evaluate the feasibility of the optimized Music-4-MS as a manualized eHealth intervention. Guided by the therapeutic music capacities model, Music-4-MS will support cognitive, psychosocial, and functional well-being. In a prospective, randomized (1:1) trial with 64 individuals with MS recruited nationwide, the Music-4-MS group will be compared with an active control group. This will be a step toward a larger clinical trial to test the intervention's efficacy in improving MS health outcomes. The specific aims are as follows:
Aim 1: To determine the feasibility and acceptability of delivering the optimized Music-4-MS eHealth intervention to individuals with MS over 12 weeks.
Aim 2: To evaluate the preliminary effect of the optimized Music-4-MS on cognitive (objective performance, subjective function), psychosocial (anxiety, depression, social function), and functional (physical function, fatigue, hand dexterity) well-being over time in the Music-4-MS versus the active control group.
Aim 3: To explore participants' perceptions of the motivation, engagement, connection, and usefulness of Music-4-MS in their daily lives.
Eligibility criteria
Inclusion Criteria:
* Diagnosed with multiple sclerosis (relapsing remitting, secondary progressive, primary progressive)
* Diagnosed more than 6 months prior to starting study
* Self-reported cognitive impairment as assessed by having at leased 5 problems "sometimes" or more often on the Perceived Deficits Questionnaire
* Read, write, and understand English
* Access to internet
Exclusion Criteria:
* Diagnosed with another neurological condition that causes cognitive impairment
* MS exacerbation within the last 30 days
* Professional musician (primary source of income)
Study design
Enrollment target: 64 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-08-10
Estimated completion: 2028-08
Last updated: 2026-08-17
Interventions
Behavioral: Music Training InterventionBehavioral: Music Listening
Primary outcomes
- • Feasibility: Engagement (Immediately post-intervention)
- • Feasibility: Retention (Immediately post-intervention)
- • Feasibility: Recruitment (Immediately post-intervention)
Sponsor
University of Texas at Austin · other
With: National Institute of Nursing Research (NINR)
Contacts & investigators
ContactCarolyn Phillips, PhD, RN · contact · carolyn.phillips@nursing.utexas.edu · 512-475-7039
InvestigatorCarolyn Phillips, PhD · principal_investigator, University of Texas at Austin
All locations (1)
University of Texas at AustinRecruiting
Austin, Texas, United States