Music-4-MS to Improve Cognition in People Living With Multiple Sclerosis: A Feasibility Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Texas at Austin

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Music Training Intervention

    Behavioral

    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.

  • Music Listening

    Behavioral

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Musical Training InterventionExperimental treatment 1 intervention
Group B: Music ListeningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Engagement

Feasibility will be assessed by quantifying weekly participation in Music-4-MS using the activity metrics from the online platform Teachable.

Time frame
Immediately post-intervention
2

Feasibility: Retention

Feasibility will be evaluated by quantifying how many participants drop out throughout the course of the study.

Time frame
Immediately post-intervention
3

Feasibility: Recruitment

Feasibility will be assessed by quantifying how many people accept the invitation to participate in the study.

Time frame
Immediately post-intervention
4

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.

Time frame
Immediately post-intervention

Secondary outcomes

1

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.

Time frame
Immediately post-intervention and 1-month post-intervention
2

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.

Time frame
Immediately post-intervention and 1-month post-intervention
3

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.

Time frame
Immediately post-intervention and 1-month post-intervention
4

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.

Time frame
Immediately post-intervention and 1-month post-intervention

Other outcomes

Sponsors and contacts

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University of Texas at Austin

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator