Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, CNS, Demyelinating Diseases, Immune System Diseases, Multiple Sclerosis, Nervous System Diseases, Pathologic Processes
Conditions
Keywords
Cognitive rehabilitation
Brief summary
Multiple sclerosis (MS) rates in the U.S. have nearly doubled over the past decade, making it a leading cause of nontraumatic functional impairment in young adults and significantly affecting cognitive function in up to 70% of people with MS. While traditional cognitive rehabilitation methods are limited in sensory engagement, music training offers a multisensory approach that enhances neuroplasticity and improves cognitive functions. This study investigates the feasibility of Music-4-MS, a 12-week music-based eHealth intervention, to support cognitive and emotional health in individuals with MS.
Detailed description
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.
Interventions
BEHAVIORALMusic Training Intervention
The Music Training Intervention (MTI) entails 12-weeks of online instruction to learn to play the ukulele. Participants will be taught the basic information on how to hold the ukulele, musical chords, strum and play popular songs. They will be instructed to play at least 30-minutes a day, five days a week.
BEHAVIORALMusic Listening
Participants randomized to this arm will be asked to listen to their preferred music for at least 30 minutes, 5 days a week. A member of our research team will call them every week to answer any questions they have about the ML protocol. They will be asked to record their experience in a daily log
Sponsors
University of Texas at Austin
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Recruitment | Immediately post-intervention | Feasibility will be assessed by quantifying how many people accept the invitation to participate in the study. |
| Musical Training Intervention Acceptability | Immediately post-intervention | Acceptability will be evaluated with semi-structured interview questions to understand the participant's perception of MTI delivery and content and the perceived impact. |
| Music Listening Intervention Acceptability | Immediately post-intervention | Acceptability will be assessed by having participants rate a series of eight statements from 1 (Strongly Disagree) to 7 (Strongly Agree), and answer three open-ended questions based on their experience with the music listening program. |
| Feasibility: Engagement | Immediately post-intervention | Feasibility will be assessed by quantifying weekly participation in Music-4-MS using the activity metrics from the online platform Teachable. |
| Feasibility: Retention | Immediately post-intervention | Feasibility will be evaluated by quantifying how many participants drop out throughout the course of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Memory Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | Immediate and delayed recognition tests will be used. Participant are shown 10 words to memorize. In the immediate recognition test, they are immediately asked to identify the 10 words they memorized out of a list of 20. Later in the testing series, participants will again be asked to recall the 10 words. The number of correct responses will be scored. Higher scores means better memory. |
| Mean Change from Baseline in Executive Functioning Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The Digit-Symbol Substitution will be used to measure processing speed and accuracy to evaluate executive functioning. In this test, participants match arbitrary symbols to digits. Scores are calculated by the number of trials correctly completed in 60 seconds. |
| Mean Change from Baseline in Functional Well-Being Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v2.0 will be used. The survey measures physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain is scored from 4 to 20. |
| Mean Change from Baseline in Upper Extremity Function Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function (Fine Motor, ADL) - Short Form will be used. The minimum score is 8, and the maximum score is 40. Higher scores indicate more more upper extremity function. |
| Mean Change from Baseline in Cognitive Function at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The Patient-Reported Outcomes Measurement Information System (PROMIS) Cognition Function Short-Form will be used. The minimum score is 8, and the maximum score is 40. Higher scores indicate more cognitive impairment. |
| Mean Change from Baseline in Objective Hand Dexterity Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The 9-Hole Peg Test (9HPT) will be used. The 9HPT is a timed task completed with both hands independently, with a lower time indicating more hand dexterity. |
| Mean Change from Baseline in Subjective Hand Dexterity Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The ABILHAND Questionnaire will be used. There are 26 activities listed and the participants responds with impossible, difficult, or easy to complete. An increased number of impossible and difficult responses indicates lower hand dexterity. |
| Mean Change from Baseline in Loneliness Scores at 12 weeks and 16 weeks. | Immediately post-intervention and 1-month post-intervention | The NIH Toolbox - Emotional Battery Loneliness will be used. It is a 5-item survey with responses graded on a 5-point scale from 'never' to 'always' assessing feelings of loneliness and social isolation. |
| Mean Change from Baseline in Attention Scores at 12 weeks and 16 weeks | Immediately post-intervention and 1-month post-intervention | The Trail Making A\&B will be used to measure attention. Trails A and B are two separate timed tests. Faster time means greater attention. |
Countries
United States
Contacts
CONTACTCarolyn Phillips, PhD, RN
PRINCIPAL_INVESTIGATORCarolyn Phillips, PhD
University of Texas at Austin
Outcome results
None listed