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

NCT ID: NCT05792176

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-10-01

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.

Detailed Description

Multiple sclerosis (MS) affects more than 2.8 million people worldwide. The prevalence has increased in every region worldwide since 2013, and in the United States, rates have nearly doubled. It is the main cause of nontraumatic disability in young adults in many countries. MS is a chronic neuroinflammatory and neurodegenerative disease with an unpredictable course. Varying visible and invisible symptoms occur in MS. The invisible symptoms, such as fatigue, depression, psychological distress, insomnia, and cognitive dysfunction pose a significant burden on quality of life (QoL) and workforce participation, rendering PwMS more vulnerable to mental health challenges compared to those affected by physical disability alone. Cognitive impairment occurs in 40-70%, depression in up to 50%, and fatigue can be present in up to 85-95% of PwMS. The interplay of cognitive impairment, mood, impaired sleep quality, and fatigue contributes significantly to worsened QoL. Cognitive impairment can occur in early and late phases of the disease and may include alterations in information processing, attention, executive functions and working memory. Multiple interventions have been created to address cognitive impairments such as conventional cognitive rehabilitation, computer-based programs, non-invasive brain stimulation, and neurologic music therapy. Many of these interventions have shown improvements in various domains of cognitive impairment. However, the effect of cognitive rehabilitation on psychosocial well-being in addition to cognitive symptoms is rare.

This research aims to fill a gap in cognitive rehabilitation with an innovative music training intervention for PwMS. Active music engagement interventions (i.e., instrument playing) have shown improvements in cognitive, motor, and psychosocial outcomes in other neurological conditions. However, few studies have examined the impact for PwMS. Most music intervention studies in PwMS evaluate the impact of music on fatigue, pain, mood disorders, walking, and balance. The impact of music on cognition is much less studied. Our team is currently conducting a systematic review examining the differences between active and passive music engagement in PwMS. Sixteen studies were included in the review. Only two studies examined active music making (singing or musical instrument playing), only one of those evaluated the impact on cognition (no improvement), and neither evaluated the effect on psychosocial (anxiety, depression, quality of life) outcomes. Twelve of the studies evaluated passive music engagement (music listening with or without movement); however, the primary outcome in most of these studies was neurological motor skills versus non-motor or psychosocial outcomes. One study, that used both active and passive musical engagement, examined the effect of cognitive rehabilitation plus neurological music therapy on cognitive abilities, mood, emotional components, and MS quality of life. They found significant improvements in cognitive function, motivation, emotional awareness, depression, and quality of life in the intervention that entailed cognitive rehabilitation plus neurological music therapy. However, no significant differences were found between the experimental group (cognitive rehabilitation plus neurological music therapy) and active control (cognitive rehabilitation alone).

Music listening and making is processed throughout spinal, subcortical, and cortical regions, and thus has meaningful and broad impacts on complex cognitive, affective, and sensorimotor processes. The impact of instrumental music playing on executive functioning has been demonstrated in many studies with children; however, this has not been studied in PwMS. Specific to executive function, neuroimaging studies with functional magnetic resonance imaging (fMRI) and functional near-infrared spectroscopy (fNIRS) show an increase in neural activations the right frontal and prefrontal regions in PwMS on cognitive tests requiring lower cognitive load (e.g., 1-back) working memory tasks when compared to healthy controls and lower activation on higher cognitive load tasks (2- and 3-back). Theoretically, it is hypothesized that the neuronal damage caused by MS causes processing resources to be diminished, thus different brain areas are recruited to cope with task demands as difficulty increases. The rehabilitative effects of music in relation to other neurological disorders is linked to changes in brain neuroplasticity, which describes the adaption and cortical reorganization after training or learning a new task. This study will examine the feasibility of an online musical training intervention (MTI) for PwMS, explore the potential effect on cognitive functioning, psychosocial, and functional well-being, and explore a neuroimaging via fNIRS, a non-invasive technique, to determine if pre-intervention brain activity predicts post-intervention cognitive functioning.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Musical Training Intervention

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.

Group Type: EXPERIMENTAL

Music Training Intervention

Intervention Type: 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.

Music Listening

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.

Group Type: ACTIVE_COMPARATOR

Music Listening

Intervention Type: 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.

Interventions

Music Training Intervention

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.

Intervention Type: BEHAVIORAL

Music Listening

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Phillips

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

STUDY00003870

Identifier Type: -

Identifier Source: org_study_id