About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosed with another neurological condition that causes cognitive impairment
MS exacerbation within the last 30 days
Professional musician (primary source of income)
Trial design
Parallel
Treatments tested in this trial
Music Training Intervention
BehavioralThe 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.
Music Listening
BehavioralParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: Engagement
Feasibility will be assessed by quantifying weekly participation in Music-4-MS using the activity metrics from the online platform Teachable.
Feasibility: Retention
Feasibility will be evaluated by quantifying how many participants drop out throughout the course of the study.
Feasibility: Recruitment
Feasibility will be assessed by quantifying how many people accept the invitation to participate in the study.
Musical Training Intervention Acceptability
Acceptability will be evaluated with semi-structured interview questions to understand the participant's perception of MTI delivery and content and the perceived impact.
Secondary outcomes
Mean Change from Baseline in Functional Well-Being Scores at 12 weeks and 16 weeks
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 Cognitive Function at 12 weeks and 16 weeks
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 Upper Extremity Function Scores at 12 weeks and 16 weeks
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 Objective Hand Dexterity Scores at 12 weeks and 16 weeks
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.
Sponsors and contacts
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University of Texas at Austin
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator