A Randomized Controlled Trial of Ukulele Playing Compared to Music Listening to Improve Cognition in People with Multiple Sclerosis: a Feasibility Study

CompletedNot a drug-phase studyRelapsing and progressiveNCT05792176

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Music Training Intervention

Compared with

  • Music Listening

What it measured

Main measures

  • Intervention Feasibility

    Immediately post-intervention

    FeasibilityQuality of life (reported by participants)
  • Intervention Acceptability

    Immediately post-intervention

    Feasibility

Other measures (9)

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

    Immediately post-intervention and 1-month post-intervention

    Mood and sleepQuality of life (reported by participants)
  • Mean Change from Baseline in Depression Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

    Mood and sleepQuality of life (reported by participants)
  • 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

    Quality of life (reported by participants)
  • Mean Change from Baseline in Sleep Disturbance Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

    Mood and sleepQuality of life (reported by participants)
  • Mean Change from Baseline in Attention Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

    Thinking and memory
  • Mean Change from Baseline in Memory Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

    Thinking and memory
  • Mean Change from Baseline in Executive Functioning Scores at 12 weeks and 16 weeks

    Immediately post-intervention and 1-month post-intervention

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 80

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Mar 2023

    2. Main results due

      Oct 2024

    3. Finished

      Oct 2024

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