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Multiple SclerosisNCT07759115

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

A study testing Music Training Intervention and Music Listening in people with Multiple Sclerosis and Pathologic Processes, run by University of Texas at Austin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Music Training Intervention and Music Listening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
10 Aug 2026to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Diagnosed with another neurological condition that causes cognitive impairment
  • MS exacerbation within the last 30 days
  • Professional musician (primary source of income)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carolyn Phillips, PhD, RN contact

512-475-7039

carolyn.phillips@nursing.utexas.edu

United States1 site, 1 recruiting
  • University of Texas at Austin

    Austin, Texas, 78712

    Carolyn Phillips, PhD, RN, 512-475-7039, music4ms@nursing.utexas.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Music Training Intervention, Music Listening
Keywords
Cognitive rehabilitation
Medical subject headings
Multiple Sclerosis, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music Training InterventionBehavioural

    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 ListeningBehavioural

    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

Study groups in NCT07759115
Study groupRoleWhat they receive
Musical Training InterventionExperimentalParticipants randomized to this arm receive a 12-week intervention to teach them how to play the ukulele. The ukulele is a very manageable instrument to learn and requires less hand dexterity than other stringed instruments. Each week participants will follow the musical training intervention (MTI) protocol that provides instruction on how to tune, hold, and strum the ukulele and play basic chords. To practice the chords, they will also learn popular songs (e.g., Chain of Fools, Three Little Birds, Happy Birthday, Just the Way You Are, and Coconut). Participants will be instructed to follow each session outlined weekly and asked to practice the instrument for at least 30 minutes, 5 days a week. They will be given a paper and digital version of the MTI protocol. A member of our research team will call the participants weekly to answer any questions about the MTI protocol.
Receives: Behavioral: Music Training Intervention
Music ListeningActive comparatorParticipants 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.
Receives: Behavioral: Music Listening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Engagement

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

    Measured: Immediately post-intervention

  2. Feasibility: Retention

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

    Measured: Immediately post-intervention

  3. Feasibility: Recruitment

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

    Measured: 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.

    Measured: Immediately post-intervention

  5. Music Listening Intervention Acceptability

    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.

    Measured: Immediately post-intervention

Secondary outcomes (10)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Immediately post-intervention and 1-month post-intervention

  5. Mean Change from Baseline in Subjective Hand Dexterity Scores at 12 weeks and 16 weeks

    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.

    Measured: Immediately post-intervention and 1-month post-intervention

  6. Mean Change from Baseline in Loneliness Scores at 12 weeks and 16 weeks.

    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.

    Measured: Immediately post-intervention and 1-month post-intervention

  7. Mean Change from Baseline in Attention Scores at 12 weeks and 16 weeks

    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.

    Measured: Immediately post-intervention and 1-month post-intervention

  8. Mean Change from Baseline in Memory Scores at 12 weeks and 16 weeks

    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.

    Measured: Immediately post-intervention and 1-month post-intervention

  9. Mean Change from Baseline in Executive Functioning Scores at 12 weeks and 16 weeks

    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.

    Measured: Immediately post-intervention and 1-month post-intervention

  10. Mean Change from Baseline in Executive Functioning Scores at 12 weeks and 16 weeks

    The Stroop Color and Word Test evaluates impulse control and inhibition to evaluate executive functioning. When the name of a color (e.g., "blue," "green," or "red") is displayed in an incongruent color, name (for example, the word "blue" printed in red), naming the color of the word takes longer and is more prone to errors than when the word and color are congruent or neutral. The scoring uses median duration of incongruent trials.

    Measured: Immediately post-intervention and 1-month post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start10 Aug 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07759115
Sponsor's protocol ID
STUDY00008963
Other IDs
R21NR022143
Status last verified
Aug 2026
First submitted
5 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Music Training Intervention and Music Listening in people with Multiple Sclerosis and Pathologic Processes, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carolyn Phillips, PhD, RN (512-475-7039, carolyn.phillips@nursing.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Engagement (time frame: Immediately post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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