Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792176
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-02-16
Brief Title:
Ukulele Playing to Improve Cognition in People With Multiple Sclerosis A Feasibility Study
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
A Randomized Controlled Trial of Ukulele Playing Compared to Music Listening to Improve Cognition in People With Multiple Sclerosis A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 28 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 ie 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 eg 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
This research aims to fill a gap in cognitive rehabilitation with an innovative music training intervention for PwMS Active music engagement interventions ie 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None