NCT07759115

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Aug 2026Aug 2028

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1.6 years

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Cognitive rehabilitation

Outcome Measures

Primary Outcomes (5)

  • Feasibility: Engagement

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

    Immediately post-intervention

  • Feasibility: Retention

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

    Immediately post-intervention

  • Feasibility: Recruitment

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

    Immediately post-intervention

  • 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.

    Immediately post-intervention

  • 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.

    Immediately post-intervention

Secondary Outcomes (10)

  • Mean Change from Baseline in Functional Well-Being Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

  • Mean Change from Baseline in Cognitive Function at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

  • Mean Change from Baseline in Upper Extremity Function Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

  • Mean Change from Baseline in Objective Hand Dexterity Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

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

    Immediately post-intervention and 1-month post-intervention

  • +5 more secondary outcomes

Study Arms (2)

Musical Training Intervention

EXPERIMENTAL

Participants 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.

Behavioral: Music Training Intervention

Music Listening

ACTIVE COMPARATOR

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.

Behavioral: Music Listening

Interventions

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.

Musical Training Intervention
Music ListeningBEHAVIORAL

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

Music Listening

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Multiple SclerosisPathologic ProcessesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsLeukoencephalopathiesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Carolyn Phillips, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Phillips, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 12, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations