NCT06174740

Brief 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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

June 21, 2023

Last Update Submit

December 4, 2024

Conditions

Keywords

auditorymultisensorystimulationauditory cuedmusic basedmusic therapy trainingrhythmic auditory stimulationDiffusion Magnetic Resonance ImagingDiffusion Tensor Imagingmotor learningmovement training

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and week 8

Secondary Outcomes (15)

  • Change in cortical thickness in motor areas from baseline at week 8

    Baseline and week 8

  • Change form baseline in task-based functional magnetic resonance imaging (fMRI) activation in the premotor cortex at week 8

    Baseline and week 8

  • Change from baseline in resting state fMRI connectivity in the auditory and sensorimotor networks at week 8

    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

    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.

    Baseline, week 4, and week 8

  • +10 more secondary outcomes

Other Outcomes (30)

  • Change from baseline in brain activation during a dual cognitive-motor interference task at week 8

    Baseline and week 8

  • Change from baseline in performance of dual cognitive-motor interference task at week 8

    Baseline and week 8

  • Changes from baseline in white matter diffusivity of the corticospinal tract at week 8

    Baseline and week 8

  • +27 more other outcomes

Study Arms (2)

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.

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

Behavioral: Visually-cued motor training

Interventions

In addition to visual cues, music stimuli guide finger sequence movement both rhythmically (temporal component) and sonically (pitch-finger alignment).

Also known as: music-based training, music-cued training, music-based motor learning, multisensory stimulation, rhythmic auditory stimulation
Music-Cued Audiovisual Motor Training

Visual cues guide finger sequence movement by indicating which finger to move in alignment with the position and of the visual cue.

Also known as: Control Group
Visually-Cued Motor Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Social Science, Leiden University

Leiden, Netherlands

Location

Related Publications (45)

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MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hanneke E Hulst, PhD

    Universiteit Leiden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The order of the allocation for new inclusions will be concealed from the assessors. Researchers administering assessments at the two time points will be masked and concealed from the randomization and participant allocation. Researchers involved in the MRI acquisition and analysis will collect the data under a different participant identifier (ID) than the ID used to conduct MRI analysis, and will follow an analysis script designed before data collection is completed, where applicable. Participants, and researchers may not be masked from the conditions due to practical reasons relating to the presence of auditory stimuli in the same or nearby vicinity, or interacting with the participants regarding the presence of auditory stimuli, which is the main intervention being investigated.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 21, 2023

First Posted

December 18, 2023

Study Start

July 1, 2023

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Coded data will be published in online scientific archive without a time limit, all participant data, including physical documents will be archived at Faculty of Social and Behavioural Sciences at Leiden university for 10 years.
Access Criteria
Coded data that cannot be traceable to the participant identifying information will be published in an online repository, the web address of the repository will be included for each publication that results from the study. No restriction to access the publicly available data will be imposed, however, future studies that use the data of the study will be required to make reference to the study AND/OR the repository.

Locations