Ukulele Playing to Improve Cognition in People with Multiple Sclerosis: a Feasibility Study

NCT05792176 | Completed

• 1 other identifier: STUDY00003870
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past 10 years, the rates of multiple sclerosis (MS) have nearly doubled in the United States. This chronic, neuroinflammatory, and neurodegenerative disease is most often diagnosed between the ages of 20-40. Cognitive impairment effects up to 70% of people with MS (PwMS) and has a detrimental impact on mental health, social connections, and employment. Further, up to 50% of PwMS also struggle with depression. Numerous cognitive rehabilitation programs are available to address cognitive impairment, but few interventions have simultaneous effects on cognition and emotional well-being. Music interventions have potential to fill this gap. Brain imaging studies on music and emotion show that music can modulate activity in the brains structures that are known to be crucially involved in emotion. Further, music engages areas of the brain that are involved with paying attention, making predictions, and updating events in our memory. The purpose of this study is to determine the feasibility of an online musical training intervention (MTI) for PwMS and explore the potential effect on cognition, psychosocial, and functional well-being compared to an active control group (music listening (ML)). The specific aims are to: 1) determine the feasibility and acceptability of delivering the MTI virtually over three months to PwMS; 2) evaluate the effect of the MTI on cognitive functioning (processing speed, working memory, cognitive flexibility, response inhibition), psychosocial (anxiety, depression, stress, quality of life, self-efficacy) and functional (insomnia) well-being compared to ML; and 3) (exploratory aim) to utilize non-invasive neuroimaging to determine if pre-intervention brain activity predicts post-intervention cognitive functioning.

Conditions

Multiple Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Keywords

cognitive rehabilitation

Outcome Measures

Primary Outcomes (4)

• Intervention Feasibility

  Feasibility will be evaluated by tracking the percentage of participants screened and enrolled.

  Immediately post-intervention

• Intervention Feasibility

  Feasibility will be evaluated by tracking the average number of participants enrolled monthly.

  Immediately post-intervention

• Intervention Feasibility

  Protocol adherence will be evaluated by recording the average number of modules completed by participants.

  Immediately post-intervention

• 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

Secondary Outcomes (10)

• Mean Change from Baseline in Anxiety Scores at 12 weeks and 16 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Depression Scores at 12 weeks and 16 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Stress Scores at 12 weeks and 16 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Self-Efficacy Scores at 12 weeks and 16 weeks

  Immediately post-intervention and 1-month post-intervention

• Mean Change from Baseline in Quality of Life Scores at 12 weeks and 16 weeks

  Immediately post-intervention and 1-month post-intervention

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, Don't Worry Be Happy, and Stand by Me). 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 practice log.

Behavioral: Music Listening

Interventions

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 handle and hold the ukulele, musical chords, and popular songs. They will be instructed to play at least 30-minutes a day, five days a week.

Musical Training Intervention

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 practice log.

Music Listening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with multiple sclerosis (relapsing remitting, secondary progression, primary progressive)
• Diagnosed more than 6 months prior to starting study
• Self-reported cognitive impairment as assessed by having at least 5 problems "sometimes" or more often on the Perceived Deficits Questionnaire
• Read, write, and understand English
• Access to computer and zoom

You may not qualify if:

• Diagnosed with another neurological condition that causes cognitive impairment
• MS exacerbation within the last 30 days
• Unable to travel to The University of Texas at Austin for fNIRS data collection
• Professional musician (primary source of income)

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases

Study Officials

• Carolyn Phillips, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

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: February 16, 2023
• First Posted: March 31, 2023
• Study Start: March 27, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)