AgingNMSOANCT06174740
Brain Imaging and Behavioural Changes Following Cued-movement Training of Finger Sequences in Healthy Older Adults
A study testing Music-cued audiovisual motor training and Visually-cued motor training in people with Aging and Music, run by Universiteit Leiden at 1 site in Netherlands.
Trial summary
The goal of this study is to examine changes in the brain, behavior, and personal experience when music is used to guide learning of finger movement sequences (compared to visual stimuli alone) in healthy older adults. The main research questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Music, Motor Activity
- What is being tested?
- Music-cued audiovisual motor training and Visually-cued motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed (assessed by the Edinburgh Handedness Inventory),
- Neurologically and physically healthy adults (a previous diagnosis of a neurological/psychiatric illness that is symptom-free and for which no treatment was necessary for at least 5 years may be included), other physical health conditions that are stable (no change in diagnosis or medication in the past 2 years may be included)
- aged 60 or older,
- Age-normal cognitive function (as assessed by a score of ≥24 on the MMSE),
- Age appropriate normal or corrected vision and hearing ability,
- Speaking fluent Dutch,
- Not currently receiving musical training.
- Participants should have access to a computer and internet to complete the training at home.
Who cannot join
- MRI contraindications (e.g., having ferromagnetic metals, such as implants, or claustrophobia)
- Starting or currently engaged in hand training, including musical training, and for example knitting, type-writing, or other hobbies (musical activities such as dancing or singing that do not involve the hand).
- Changes in medications that may affect fMRI measures.
- Not being able to follow the training at the laboratory or at home, or not completing the practice at home despite alerts and reminders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Correlates of Multisensory Stimulation in Healthy Older Adults
The goal of this study is to examine changes in the brain, behavior, and personal experience when music is used to guide learning of finger movement sequences (compared to visual stimuli alone) in healthy older adults. The main research questions this study aims to answer are:
- Is auditory-based motor training associated with increased structural integrity of brain white matter tracts (connecting auditory-motor regions) compared to motor training with visual cues only?
- Is auditory-based motor training (as compared to visual clues only) associated with increased brain cortical thickness, and changes in brain activation while performing a task in the MRI and while at rest, in auditory and sensorimotor regions?
- Does auditory-based motor training lead to greater motor improvement on the trained task compared to a visually cued motor training?
- Does auditory-based motor training lead to greater improvement on thinking, movement, and self-reported wellbeing measures, compared to visual cues alone?
Read more
In an 8-week home training, participants will be randomized into either the music-cued motor learning (Experimental Group) or visually cued only condition (Control Group), participants will complete the following measures before-and-after the training is administered at week 1 and in the end of the 8-week trial:
- MRI scans (structural and functional)
- Behavioral measures (motor, cognition)
- Questionnaires administered pre-and-post training (psychosocial functioning).
- Questionnaires administered once only (personality traits, musical background)
- In between measures, participants will follow an online computer-based training at home of 20 minutes per session, 3 times per week for 8 weeks, for a total of 24 sessions constituting 8 hours of training.
Read the detailed description
Rationale: Music interventions targeting motor recovery are increasingly used in clinical settings with motorically impaired patients. In recent years, research started to demonstrate the mechanism underlying motor recovery by moving to music. While neuroimaging studies began to elucidate the neural correlates of music-based movement, most of these studies have been conducted on young adults, whereas the average age at onset of movement disorders which are the target of music therapy is in the 6th decade of life. Therefore, in this study the investigators aim to elucidate the underlying mechanisms of music-based movement in healthy older adults using a motor learning, finger sequence task to a musical rhythm. The results of the study have implications for motor learning with music in the aging person and neural plasticity in old age, and may reveal the benefit of adding music-cues to motor activities for motor, cognitive, and motivational outcomes in older adults.
Objective: The goal of the current study is to examine structural and functional neural correlates, as well as changes in behavioral and self-report measures of audiovisual music-based motor training compared to an identical motor training using visual cues only. The study focuses on white matter changes as the primary objective as the researchers are interested in connections between auditory and motor brain regions implicated in music-cued motor training. The research will examine brain activation, and changes in grey matter volume as secondary neuroimaging outcomes. Moreover, the study will also examine improvement on the trained task (outside of the MRI scanner), and changes on standardized measures of motor and cognitive function, as well as self-report measures of psychological wellbeing.
The main hypothesis is that the music-based motor training group will show greater white matter integrity of the arcuate fasciculus and greater density of cortical thickness in motor areas in the right brain hemisphere opposite to the trained left hand, as well as greater changes in brain activation while performing the task and at rest. The music group is expected to show greater improvement on the trained task, and measures of motor and cognitive function, as well as self-report measures of wellbeing (motivational, mood, and experience). As an exploratory measure, the study will assess changes in dual-task interference before and after the training as a far-transfer measure of the training, both in motor function and the underlying brain function.
Study design: In an 8-week longitudinal between-group design, participants will be randomized into two groups and will participate in pre-and-post MRI scans and behavioral measures, administered at baseline (week 1) and end of trial (week 8). The learning of an audio-visual finger movement sequence task will be compared to training on the same motor sequence with visual cues only. Participants will be assessed before and after the 8-week training on MRI and behavioral measures.
Study population: A total of 50 healthy older adults (60 years and older) will be recruited for this study and randomized into two groups of 25 participants each. Inclusion criteria are being right-handed (assessed by the Edinburgh Handedness Inventory), neurologically and physically healthy adult aged 60 or older (a previous diagnosis of a neurological/psychiatric illness that is symptom-free and for which no treatment was necessary for at least 5 years may be included), other physical health conditions that are stable (no change in diagnosis or treatment in the past 2 years may be included), having age-normal cognitive function (as assessed by a score of ≥24 on the MMSE), age appropriate normal or corrected vision and hearing ability, speaking fluent Dutch, and not currently receiving musical training. Participants should have access to a computer to complete the training at home. Participants will be recruited through various channels in the Netherlands including ageing organizations, (social) media, and study recruitment websites.
Sample Size: In a previous study with a longitudinal design using the same learning task in healthy young adults, the researchers found a medium size effect for changes in white matter tracts connecting auditory and motor regions (i.e., arcuate fasciculus) in the brain hemisphere opposite the trained hand. Therefore, it is estimated that the sample size needed to show a similar medium sized effect would be 22 per group, however, this number is increased to 25 healthy older participants per group to account for additional drop out at the analysis stage.
Intervention: Two groups will receive a similar intervention of finger sequence movement learning following visual cues with (or without) rhythmic auditory stimulation. Participants will be trained on the task at the laboratory before baseline measures. Participants will continue training at home online on a computer and keyboard for 20 minutes per session 3 times per week for 8 weeks for a total of 24 sessions. The Music group will train the finger sequence with the aid of visual cues in synchrony with a musical rhythm, while the Control group will receive the same visual stimulation with no auditory component.
Main study parameters/endpoints: The main parameter is change in white matter tracts underlying auditory-motor regions (arcuate fasciculus) in the brain hemisphere opposite the trained hand, contrasting before and after training, and between hemispheres. Secondary MRI parameters focus on cortical thickness changes in primary, premotor, and supplementary motor areas, task-related brain activation in the premotor cortex, and resting-state functional connectivity of auditory-motor regions. Motor performance on the cued motor sequence task will be assessed by measuring the accuracy of the key presses and the timing stability in synchrony with the onset of the cue. Changes in the scores of standardized motor and cognitive measures, and self-reported questionnaires on motivational and mood indices will be compared between groups and timepoints. As an exploratory outcome, the study will also assess changes in dual-task interference before and after the training both behaviorally and in terms of associated brain activity while performing the task.
- Conditions
- Aging, Music, Motor Activity, Magnetic Resonance Imaging, Neuronal Plasticity
- Being tested
- Music-cued audiovisual motor training, Visually-cued motor training
- Keywords
- auditory, multisensory, stimulation, auditory cued, music based, music therapy training, rhythmic auditory stimulation, Diffusion Magnetic Resonance Imaging, Diffusion Tensor Imaging, motor learning, movement training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-cued audiovisual motor trainingBehavioural
Also called music-based training, music-cued training, music-based motor learning, multisensory stimulation
In addition to visual cues, music stimuli guide finger sequence movement both rhythmically (temporal component) and sonically (pitch-finger alignment).
Visually-cued motor trainingBehavioural
Also called Control Group
Visual cues guide finger sequence movement by indicating which finger to move in alignment with the position and of the visual cue.
| Study group | Role | What they receive |
|---|---|---|
| Music-Cued Audiovisual Motor Training | Experimental | Participants will be instructed on the task which they will perform at home online using a keyboard. The training involved auditory-cued audiovisual finger movement sequence learning task. Participants will complete an online computer-based training of 20 minutes at home 3 times per week for the duration of 8 weeks, and a total of 24 sessions, the duration and number of sessions. Receives: Behavioral: Music-cued audiovisual motor training |
| Visually-Cued Motor Training | Active comparator | Participants will be instructed on the task which they will perform at home online using a keyboard. The training involved visual cues for finger-movement sequence learning task. Participants will complete an online computer-based training of 20 minutes at home 3 times per week for the duration of 8 weeks, and a total of 24 sessions, the duration and number of sessions Receives: Behavioral: Visually-cued motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in white matter diffusivity of the arcuate fasciculus
Change to white matter diffusivity (baseline to post training; within and between hemispheres contralateral to the trained vs. untrained hand) will be assessed by comparing fractional anisotropy (FA) radial diffusivity (RD), and mean diffusivity (MD) of the left and right arcuate fasciculus between groups across the two timepoints, pre-and post-training in the hemisphere contralateral to the trained hand, and between the hemispheres.
Measured: Baseline and week 8
Secondary outcomes (15)
Change in cortical thickness in motor areas from baseline at week 8
Change from baseline in cortical thickness of the primary, premotor, and supplementary motor areas contralateral to the trained hand before and after training will be compared between the musical group and the control group focusing on regions of interest in sensorimotor areas. Cortical thickness is measured using an initial surface generated for each hemisphere by tiling the outside of the white matter mass for that hemisphere. This initial surface is then refined to follow the intensity gradients between the white and gray matter (this is referred to as the white surface). The white surface is then nudged to follow the intensity gradients between the gray matter and cerebrospinal fluid (this is the pial surface). The white and pial surfaces are overlaid on the original T1-weighed image, and the distance between the white and the pial surfaces is measured to determine the thickness at each location of cortex.
Measured: Baseline and week 8
Change form baseline in task-based functional magnetic resonance imaging (fMRI) activation in the premotor cortex at week 8
Change from baseline in task-based functional MRI activation (Blood Oxygen Level Dependent; BOLD) in the premotor cortex, examining the contrast (Cued Tapping vs Rest) at week 8.
Measured: Baseline and week 8
Change from baseline in resting state fMRI connectivity in the auditory and sensorimotor networks at week 8
Change from baseline in resting state connectivity will focus on nodes of auditory network and sensorimotor network strength in functional MRI activation at week 8
Measured: Baseline and week 8
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits, and mid-trial online) based on accuracy of the key presses
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits of the 8-week training, and mid-trial at week 4 online) based on accuracy of the key presses. The number of correctly performed motor sequences and movement will be averaged for trained and untrained sequences.
Measured: Baseline, week 4, and week 8
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits, and mid-trial online) based on the timing stability and synchrony with the onset of the cue.
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits of the 8 week training, and mid-trial at week 4 online) based on the timing stability in synchrony with the onset of the cue. The number of correctly performed motor sequences and movement will be averaged.
Measured: Baseline, week 4, and week 8
Change from baseline in the scores of Grooved Pegboard Task at week 8
Change from baseline to week 8 in scores of the Grooved Pegboard Task (measured in time in seconds) for both the dominant and non-dominant hand. A total of 240 seconds is the maximum allowed (minimum of 0), where a higher score indicates worse outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Box and Blocks Test at week 8
Change from baseline to week 8 in scores of the Box and Block test (measured in number of blocks transferred in one minute, rule breaks are deducted) for both the dominant and non-dominant hand. A score of 150 is the maximum (minimum of 0), where a higher score indicates a better outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Digit Span Forward at week 8
Change from baseline to week 8 in scores of the Digit Span task (number of correctly recalled digits in a sequence is recorded), a maximum score of 2-9, with a higher score meaning a better outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Digit Span Backwards at week 8
Change from baseline to week 8 in scores of the Digit Span task (number of correctly recalled digits in a sequence is recorded) with a score ranging from 2-8 and a higher score indicating better outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Trail Making Test at week 8
Change from baseline to week 8 in scores of the Trail Making Test (measured in time over 5 trials). The final score is trial 4 (letter-switching) (score range: 0-240) minus the average of trials 1,2, 3, and 5 (Visual scanning, number sequencing, letter sequencing, and motor speed, respectively). The minimum possible score is 0 and the maximum is 240, where a higher score indicates a worse outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Stroop Color Word Interference Test at week 8
Change from baseline to week 8 in scores of the Stroop Color Word Interference Test (the combined time during the two congruent trials is subtracted from the time during the non-congruent trial), the lowest possible score is 0 and the maximum is 180, where a higher score indicates a worse outcome.
Measured: Baseline and week 8
Change from baseline in the scores of Verbal Fluency Test at week 8
Change from baseline to week 8 in scores of the Verbal Fluency Test (total number of correct responses across trials excluding repeats, and deducting errors for phonemic and categorical subtests are recorded), where a higher score indicates better performance, a minimum of 0 and a maximum of 480.
Measured: Baseline and week 8
Change from baseline in the scores of Rey Auditory Verbal-Learning Test at week 8
Change from baseline to week 8 in scores of the Rey Auditory Verbal-Learning Test, the number of correct responses is recorded for both immediate, interference and delayed recall trials, the final score is the highest achieved number on the learning trails (0 - 15) minus the delayed recall score (0 - 15), where a higher score indicates a worse outcome. The maximum score is 15 and the lowest is -15.
Measured: Baseline and week 8
Change from baseline in scores of Quality of Life measure at week 8
Change from baseline to week 8 in scores of the EuroQol- 5 (Dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) range from 1-5 where a higher number is a worse outcome, and a visual analogue scale from 0-100 where a higher number is a better outcome.
Measured: Baseline and week 8
Change from baseline in scores of mood measure at week 8
Change from baseline to week 8 in scores of the Depression Anxiety Stress Scale, where Depression symptoms related items: 3, 5, 10, 13, 16, 17, 21 (range from 0-21) Anxiety disorder-related items: 2, 4, 7, 9, 15, 19, 20 (range from 0-21) Stress-related items: 1, 6, 8, 11, 12, 14, 18 (range from 0-21), where a higher score indicates a worse outcome for all domains.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jul 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into either the audiovisual condition (Experimental Group) or visual cues only condition (Control Group). A randomization list stratified by gender will be generated before commencing data collection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Schaefer, Universiteit Leiden
- Investigators
- Hanneke E Hulst, PhD, Study chair, Universiteit Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174740
- Sponsor's protocol ID
- 2022-08-23-RS Schaefer-V2-4097
- Acronym
- NMSOA
- Status last verified
- Dec 2024
- First submitted
- 21 Jun 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data relating to the main outcomes will be shared in online repository. Coded data will be published in an online scientific archive for the purpose of future research, in line with Open Science practices, and for the verification of findings for 10 years according to the Data Management Guidelines of the Health, Medical, and Neuropsychology Unit (v171220), Institute of Psychology, Faculty of Social and Behavioural Sciences at Leiden University. These data would not be traceable as they are not linked in any way to personal data. MRI data will be stored in the Open Science Framework (OSF) data repository and other platforms that may accommodate the large capacity of the data set.
Publications
Aloufi AE, Rowe FJ, Meyer GF. Behavioural performance improvement in visuomotor learning correlates with functional and microstructural brain changes. Neuroimage. 2021 Feb 15;227:117673. doi: 10.1016/j.neuroimage.2020.117673. Epub 2020 Dec 24.
PubMed 33359355Bermudez P, Lerch JP, Evans AC, Zatorre RJ. Neuroanatomical correlates of musicianship as revealed by cortical thickness and voxel-based morphometry. Cereb Cortex. 2009 Jul;19(7):1583-96. doi: 10.1093/cercor/bhn196. Epub 2008 Dec 10.
PubMed 19073623Blecher T, Tal I, Ben-Shachar M. White matter microstructural properties correlate with sensorimotor synchronization abilities. Neuroimage. 2016 Sep;138:1-12. doi: 10.1016/j.neuroimage.2016.05.022. Epub 2016 May 7.
PubMed 27165760Brown RM, Penhune VB. Efficacy of Auditory versus Motor Learning for Skilled and Novice Performers. J Cogn Neurosci. 2018 Nov;30(11):1657-1682. doi: 10.1162/jocn_a_01309. Epub 2018 Aug 29.
PubMed 30156505de Manzano O, Ullen F. Same Genes, Different Brains: Neuroanatomical Differences Between Monozygotic Twins Discordant for Musical Training. Cereb Cortex. 2018 Jan 1;28(1):387-394. doi: 10.1093/cercor/bhx299.
PubMed 29136105Chen JL, Rae C, Watkins KE. Learning to play a melody: an fMRI study examining the formation of auditory-motor associations. Neuroimage. 2012 Jan 16;59(2):1200-8. doi: 10.1016/j.neuroimage.2011.08.012. Epub 2011 Aug 16.
PubMed 21871571Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
PubMed 16777432Denissen JJA, Geenen R, Soto CJ, John OP, van Aken MAG. The Big Five Inventory-2: Replication of Psychometric Properties in a Dutch Adaptation and First Evidence for the Discriminant Predictive Validity of the Facet Scales. J Pers Assess. 2020 May-Jun;102(3):309-324. doi: 10.1080/00223891.2018.1539004. Epub 2019 Jan 14.
PubMed 30638406EuroQol Research Foundation. (2019). EQ-5D-5L User Guide. https://euroqol.org/publications/user-guides/
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Fine, E. M., & Delis, D. C. (2011). Delis-Kaplan Executive Functioning System. In J. S. Kreutzer, J. DeLuca, & B. Caplan (Eds.), Encyclopedia of Clinical Neuropsychology (pp. 796-801). Springer. https://doi.org/10.1007/978-0-387-79948-3_1539
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gaser C, Schlaug G. Brain structures differ between musicians and non-musicians. J Neurosci. 2003 Oct 8;23(27):9240-5. doi: 10.1523/JNEUROSCI.23-27-09240.2003.
PubMed 14534258Guo P, Li Q, Wang X, Li X, Wang S, Xie Y, Xie Y, Fu Z, Zhang X, Li S. Structural Covariance Changes of Anterior and Posterior Hippocampus During Musical Training in Young Adults. Front Neuroanat. 2020 May 19;14:20. doi: 10.3389/fnana.2020.00020. eCollection 2020.
PubMed 32508600Herholz SC, Coffey EB, Pantev C, Zatorre RJ. Dissociation of Neural Networks for Predisposition and for Training-Related Plasticity in Auditory-Motor Learning. Cereb Cortex. 2016 Jul;26(7):3125-34. doi: 10.1093/cercor/bhv138. Epub 2015 Jul 1.
PubMed 26139842
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Multisensory Stimulation in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT06174740
- Acronym / sponsor ID
- NMSOA / 2022-08-23-RS Schaefer-V2-4097
- Conditions
- Aging, Music, Motor Activity, Magnetic Resonance Imaging, Neuronal Plasticity
- Keywords
- auditory, multisensory, stimulation, auditory cued, music based, music therapy training, rhythmic auditory stimulation, Diffusion Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine changes in the brain, behavior, and personal experience when music is used to guide learning of finger movement sequences (compared to visual stimuli alone) in healthy older adults. The main research questions this study aims to answer are:
- Is auditory-based motor training associated with increased structural integrity of brain white matter tracts (connecting auditory-motor regions) compared to motor training with visual cues only?
- Is auditory-based motor training (as compared to visual clues only) associated with increased brain cortical thickness, and changes in brain activation while performing a task in the MRI and while at rest, in auditory and sensorimotor regions?
- Does auditory-based motor training lead to greater motor improvement on the trained task compared to a visually cued motor training?
- Does auditory-based motor training lead to greater improvement on thinking, movement, and self-reported wellbeing measures, compared to visual cues alone?
In an 8-week home training, participants will be randomized into either the music-cued motor learning (Experimental Group) or visually cued only condition (Control Group), participants will complete the following measures before-and-after the training is administered at week 1 and in the end of the 8-week trial:
- MRI scans (structural and functional)
- Behavioral measures (motor, cognition)
- Questionnaires administered pre-and-post training (psychosocial functioning).
- Questionnaires administered once only (personality traits, musical background)
- In between measures, participants will follow an online computer-based training at home of 20 minutes per session, 3 times per week for 8 weeks, for a total of 24 sessions constituting 8 hours of training.
Detailed description
Rationale: Music interventions targeting motor recovery are increasingly used in clinical settings with motorically impaired patients. In recent years, research started to demonstrate the mechanism underlying motor recovery by moving to music. While neuroimaging studies began to elucidate the neural correlates of music-based movement, most of these studies have been conducted on young adults, whereas the average age at onset of movement disorders which are the target of music therapy is in the 6th decade of life. Therefore, in this study the investigators aim to elucidate the underlying mechanisms of music-based movement in healthy older adults using a motor learning, finger sequence task to a musical rhythm. The results of the study have implications for motor learning with music in the aging person and neural plasticity in old age, and may reveal the benefit of adding music-cues to motor activities for motor, cognitive, and motivational outcomes in older adults.
Objective: The goal of the current study is to examine structural and functional neural correlates, as well as changes in behavioral and self-report measures of audiovisual music-based motor training compared to an identical motor training using visual cues only. The study focuses on white matter changes as the primary objective as the researchers are interested in connections between auditory and motor brain regions implicated in music-cued motor training. The research will examine brain activation, and changes in grey matter volume as secondary neuroimaging outcomes. Moreover, the study will also examine improvement on the trained task (outside of the MRI scanner), and changes on standardized measures of motor and cognitive function, as well as self-report measures of psychological wellbeing.
The main hypothesis is that the music-based motor training group will show greater white matter integrity of the arcuate fasciculus and greater density of cortical thickness in motor areas in the right brain hemisphere opposite to the trained left hand, as well as greater changes in brain activation while performing the task and at rest. The music group is expected to show greater improvement on the trained task, and measures of motor and cognitive function, as well as self-report measures of wellbeing (motivational, mood, and experience). As an exploratory measure, the study will assess changes in dual-task interference before and after the training as a far-transfer measure of the training, both in motor function and the underlying brain function.
Study design: In an 8-week longitudinal between-group design, participants will be randomized into two groups and will participate in pre-and-post MRI scans and behavioral measures, administered at baseline (week 1) and end of trial (week 8). The learning of an audio-visual finger movement sequence task will be compared to training on the same motor sequence with visual cues only. Participants will be assessed before and after the 8-week training on MRI and behavioral measures.
Study population: A total of 50 healthy older adults (60 years and older) will be recruited for this study and randomized into two groups of 25 participants each. Inclusion criteria are being right-handed (assessed by the Edinburgh Handedness Inventory), neurologically and physically healthy adult aged 60 or older (a previous diagnosis of a neurological/psychiatric illness that is symptom-free and for which no treatment was necessary for at least 5 years may be included), other physical health conditions that are stable (no change in diagnosis or treatment in the past 2 years may be included), having age-normal cognitive function (as assessed by a score of ≥24 on the MMSE), age appropriate normal or corrected vision and hearing ability, speaking fluent Dutch, and not currently receiving musical training. Participants should have access to a computer to complete the training at home. Participants will be recruited through various channels in the Netherlands including ageing organizations, (social) media, and study recruitment websites.
Sample Size: In a previous study with a longitudinal design using the same learning task in healthy young adults, the researchers found a medium size effect for changes in white matter tracts connecting auditory and motor regions (i.e., arcuate fasciculus) in the brain hemisphere opposite the trained hand. Therefore, it is estimated that the sample size needed to show a similar medium sized effect would be 22 per group, however, this number is increased to 25 healthy older participants per group to account for additional drop out at the analysis stage.
Intervention: Two groups will receive a similar intervention of finger sequence movement learning following visual cues with (or without) rhythmic auditory stimulation. Participants will be trained on the task at the laboratory before baseline measures. Participants will continue training at home online on a computer and keyboard for 20 minutes per session 3 times per week for 8 weeks for a total of 24 sessions. The Music group will train the finger sequence with the aid of visual cues in synchrony with a musical rhythm, while the Control group will receive the same visual stimulation with no auditory component.
Main study parameters/endpoints: The main parameter is change in white matter tracts underlying auditory-motor regions (arcuate fasciculus) in the brain hemisphere opposite the trained hand, contrasting before and after training, and between hemispheres. Secondary MRI parameters focus on cortical thickness changes in primary, premotor, and supplementary motor areas, task-related brain activation in the premotor cortex, and resting-state functional connectivity of auditory-motor regions. Motor performance on the cued motor sequence task will be assessed by measuring the accuracy of the key presses and the timing stability in synchrony with the onset of the cue. Changes in the scores of standardized motor and cognitive measures, and self-reported questionnaires on motivational and mood indices will be compared between groups and timepoints. As an exploratory outcome, the study will also assess changes in dual-task interference before and after the training both behaviorally and in terms of associated brain activity while performing the task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into either the audiovisual condition (Experimental Group) or visual cues only condition (Control Group). A randomization list stratified by gender will be generated before commencing data collection.
| Arm | Type | Receives |
|---|---|---|
| Music-Cued Audiovisual Motor Training | Experimental | Behavioral: Music-cued audiovisual motor trainingParticipants will be instructed on the task which they will perform at home online using a keyboard. The training involved auditory-cued audiovisual finger movement sequence learning task. Participants will complete an online computer-based training of 20 minutes at home 3 times per week for the duration of 8 weeks, and a total of 24 sessions, the duration and number of sessions. |
| Visually-Cued Motor Training | Active comparator | Behavioral: Visually-cued motor trainingParticipants will be instructed on the task which they will perform at home online using a keyboard. The training involved visual cues for finger-movement sequence learning task. Participants will complete an online computer-based training of 20 minutes at home 3 times per week for the duration of 8 weeks, and a total of 24 sessions, the duration and number of sessions |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Right-handed (assessed by the Edinburgh Handedness Inventory),
- Neurologically and physically healthy adults (a previous diagnosis of a neurological/psychiatric illness that is symptom-free and for which no treatment was necessary for at least 5 years may be included), other physical health conditions that are stable (no change in diagnosis or medication in the past 2 years may be included)
- aged 60 or older,
- Age-normal cognitive function (as assessed by a score of ≥24 on the MMSE),
- Age appropriate normal or corrected vision and hearing ability,
Key exclusion criteria (4 listed)
- MRI contraindications (e.g., having ferromagnetic metals, such as implants, or claustrophobia)
- Starting or currently engaged in hand training, including musical training, and for example knitting, type-writing, or other hobbies (musical activities such as dancing or singing that do not involve the hand).
- Changes in medications that may affect fMRI measures.
- Not being able to follow the training at the laboratory or at home, or not completing the practice at home despite alerts and reminders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-cued audiovisual motor trainingAlso: music-based training, music-cued training, music-based motor learning, multisensory stimulationIn addition to visual cues, music stimuli guide finger sequence movement both rhythmically (temporal component) and sonically (pitch-finger alignment). | Behavioural | Music-Cued Audiovisual Motor Training |
| Visually-cued motor trainingAlso: Control GroupVisual cues guide finger sequence movement by indicating which finger to move in alignment with the position and of the visual cue. | Behavioural | Visually-Cued Motor Training |
Primary outcome
Change from baseline to week 8 in white matter diffusivity of the arcuate fasciculus
Time frame: Baseline and week 8
Change to white matter diffusivity (baseline to post training; within and between hemispheres contralateral to the trained vs. untrained hand) will be assessed by comparing fractional anisotropy (FA) radial diffusivity (RD), and mean diffusivity (MD) of the left and right arcuate fasciculus between groups across the two timepoints, pre-and post-training in the hemisphere contralateral to the trained hand, and between the hemispheres.
15 secondary outcomes
Change in cortical thickness in motor areas from baseline at week 8
Time frame: Baseline and week 8
Change form baseline in task-based functional magnetic resonance imaging (fMRI) activation in the premotor cortex at week 8
Time frame: Baseline and week 8
Change from baseline in resting state fMRI connectivity in the auditory and sensorimotor networks at week 8
Time frame: Baseline and week 8
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits, and mid-trial online) based on accuracy of the key presses
Time frame: Baseline, week 4, and week 8
Motor performance on the cued motor sequence task across three time points (pre-post measurement visits, and mid-trial online) based on the timing stability and synchrony with the onset of the cue.
Time frame: Baseline, week 4, and week 8
Change from baseline in the scores of Grooved Pegboard Task at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Box and Blocks Test at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Digit Span Forward at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Digit Span Backwards at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Trail Making Test at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Stroop Color Word Interference Test at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Verbal Fluency Test at week 8
Time frame: Baseline and week 8
Change from baseline in the scores of Rey Auditory Verbal-Learning Test at week 8
Time frame: Baseline and week 8
Change from baseline in scores of Quality of Life measure at week 8
Time frame: Baseline and week 8
Change from baseline in scores of mood measure at week 8
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 33359355Aloufi AE, Rowe FJ, Meyer GF. Behavioural performance improvement in visuomotor learning correlates with functional and microstructural brain changes. Neuroimage. 2021 Feb 15;227:117673. doi: 10.1016/j.neuroimage.2020.117673. Epub 2020 Dec 24.
- Background: PubMed 19073623Bermudez P, Lerch JP, Evans AC, Zatorre RJ. Neuroanatomical correlates of musicianship as revealed by cortical thickness and voxel-based morphometry. Cereb Cortex. 2009 Jul;19(7):1583-96. doi: 10.1093/cercor/bhn196. Epub 2008 Dec 10.
- Background: PubMed 27165760Blecher T, Tal I, Ben-Shachar M. White matter microstructural properties correlate with sensorimotor synchronization abilities. Neuroimage. 2016 Sep;138:1-12. doi: 10.1016/j.neuroimage.2016.05.022. Epub 2016 May 7.
- Background: PubMed 30156505Brown RM, Penhune VB. Efficacy of Auditory versus Motor Learning for Skilled and Novice Performers. J Cogn Neurosci. 2018 Nov;30(11):1657-1682. doi: 10.1162/jocn_a_01309. Epub 2018 Aug 29.
- Background: PubMed 29136105de Manzano O, Ullen F. Same Genes, Different Brains: Neuroanatomical Differences Between Monozygotic Twins Discordant for Musical Training. Cereb Cortex. 2018 Jan 1;28(1):387-394. doi: 10.1093/cercor/bhx299.
- Background: PubMed 21871571Chen JL, Rae C, Watkins KE. Learning to play a melody: an fMRI study examining the formation of auditory-motor associations. Neuroimage. 2012 Jan 16;59(2):1200-8. doi: 10.1016/j.neuroimage.2011.08.012. Epub 2011 Aug 16.
- Background: PubMed 16777432Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
- Background: PubMed 30638406Denissen JJA, Geenen R, Soto CJ, John OP, van Aken MAG. The Big Five Inventory-2: Replication of Psychometric Properties in a Dutch Adaptation and First Evidence for the Discriminant Predictive Validity of the Facet Scales. J Pers Assess. 2020 May-Jun;102(3):309-324. doi: 10.1080/00223891.2018.1539004. Epub 2019 Jan 14.
- BackgroundEuroQol Research Foundation. (2019). EQ-5D-5L User Guide. https://euroqol.org/publications/user-guides/
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- BackgroundFine, E. M., & Delis, D. C. (2011). Delis-Kaplan Executive Functioning System. In J. S. Kreutzer, J. DeLuca, & B. Caplan (Eds.), Encyclopedia of Clinical Neuropsychology (pp. 796-801). Springer. https://doi.org/10.1007/978-0-387-79948-3_1539
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Individual participant dataSharing planned: Yes. Data relating to the main outcomes will be shared in online repository. Coded data will be published in an online scientific archive for the purpose of future research, in line with Open Science practices, and for the verification of findings for 10 years according to the Data Management Guidelines of the Health, Medical, and Neuropsychology Unit (v171220), Institute of Psychology, Faculty of Social and Behavioural Sciences at Leiden University. These data would not be traceable as they are not linked in any way to personal data. MRI data will be stored in the Open Science Framework (OSF) data repository and other platforms that may accommodate the large capacity of the data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanneke E Hulst, PhD study chair
Universiteit Leiden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-cued audiovisual motor training and Visually-cued motor training in people with Aging and Music, run by Universiteit Leiden at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 8 in white matter diffusivity of the arcuate fasciculus (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174740, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.