Brain Imaging and Behavioural Changes Following Cued-movement Training of Finger Sequences in Healthy Older Adults
NCT06174740, Not applicable, Completed, Universiteit Leiden
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Imaging and Behavioural Changes Following Cued-movement Training of Finger Sequences in Healthy Older Adults | ClinicalTrials.gov |
| NCT number | NCT06174740 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universiteit Leiden | ClinicalTrials.gov |
| Conditions | Aging, Music, Motor Activity, Magnetic Resonance Imaging, Neuronal Plasticity | ClinicalTrials.gov |
| Interventions | Music-cued audiovisual motor training, Visually-cued motor training | ClinicalTrials.gov |
| First posted | 2023-12-18 | ClinicalTrials.gov |
| Last updated | 2024-12-05 | ClinicalTrials.gov |
Registered outcomes 46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline to week 8 in white matter diffusivity of the arcuate fasciculus | 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. | ClinicalTrials.gov |
| Secondary | Change in cortical thickness in motor areas from baseline at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | 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 task-based functional MRI activation (Blood Oxygen Level Dependent; BOLD) in the premotor cortex, examining the contrast (Cued Tapping vs Rest) at week 8. | ClinicalTrials.gov |
| Secondary | Change from baseline in resting state fMRI connectivity in the auditory and sensorimotor networks at week 8 | Baseline and 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 | ClinicalTrials.gov |
| Secondary | 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 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. | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Grooved Pegboard Task at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Box and Blocks Test at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Digit Span Forward at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Digit Span Backwards at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Trail Making Test at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Stroop Color Word Interference Test at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Verbal Fluency Test at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in the scores of Rey Auditory Verbal-Learning Test at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in scores of Quality of Life measure at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in scores of mood measure at week 8 | Baseline and 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. | ClinicalTrials.gov |
| Other | Change from baseline in brain activation during a dual cognitive-motor interference task at week 8 | Baseline and week 8 | Change from baseline to week 8 in brain activation during a dual cognitive-motor interference task at week 8. Participants are asked to conduct a finger tapping task, and a letter counting task separately (Single Task condition), and a third trial in which participants are asked to perform both tasks simultaneously (Dual Task condition), fMRI cortical activation will be compared at baseline and at week 8 by canceling the role of the single tasks from the dual task, and comparing the two groups. | ClinicalTrials.gov |
| Other | Change from baseline in performance of dual cognitive-motor interference task at week 8 | Baseline and week 8 | Change from baseline to week 8 in performance of the dual cognitive-motor interference task at week 8. Participants are asked to conduct a finger tapping task, and a letter counting task separately (Single Task condition), and a third trial in which participants are asked to perform both tasks simultaneously (Dual Task condition). Scores on the task will be compared at baseline and at week 8 by contrasting the role of the single tasks from the dual task and quantifying any decreases/interference related to the dual task, and comparing the two groups. | ClinicalTrials.gov |
| Other | Changes from baseline in white matter diffusivity of the corticospinal tract at week 8 | Baseline and week 8 | Changes (baseline to post training; within and between hemispheres contralateral to the trained vs. untrained hand) comparing fractional anisotropy, radial diffusivity, and mean diffusivity of the corticospinal tract between groups across the two timepoints, pre-and post-training in the hemisphere contralateral to the trained hand, and between the hemispheres. | ClinicalTrials.gov |
| Other | Change from baseline in associations between cognitive and white matter diffusivity measures at week 8. | Baseline and week 8 | Change in the strength of the associations (if any) between cognitive measures (based on a composite score including scores from Digit Span Forward, Digit Span Backwards, Trail Making Test (inverted to indicate better outcome with higher number), Stroop Color Word Interference (inverted to indicate better outcome with higher number), Verbal Fluency Test, and the Rey Auditory Verbal-Learning Test), and self-report measures and trained tasks) and MRI changes in white matter diffusivity (as measured by fractional anisotropy of the left arcuate fasciculus measures) at baseline and at week 8. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 37
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 1202204 | BACKGROUND | PubMed |
| 3160243 | BACKGROUND | PubMed |
| 5146491 | BACKGROUND | PubMed |
| 10984517 | BACKGROUND | PubMed |
| 12391568 | BACKGROUND | PubMed |
| 14534258 | BACKGROUND | PubMed |
| 15501092 | BACKGROUND | PubMed |
| 16777432 | BACKGROUND | PubMed |
| 17695343 | BACKGROUND | PubMed |
| 19073623 | BACKGROUND | PubMed |
| 20688175 | BACKGROUND | PubMed |
| 21871571 | BACKGROUND | PubMed |
| 21979382 | BACKGROUND | PubMed |
| 23054237 | BACKGROUND | PubMed |
| 23616433 | BACKGROUND | PubMed |
| 25440305 | BACKGROUND | PubMed |
| 26139842 | BACKGROUND | PubMed |
| 26865518 | BACKGROUND | PubMed |
| 26966157 | BACKGROUND | PubMed |
| 27165760 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Other outcome | ConductCognition |
| Motor Sequence Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)