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Multiple SclerosisNCT04639401

Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

A study testing motor entrainment to auditory cues and music during walking on quality of movement in people with Multiple Sclerosis and Cerebral Lesion, run by Hasselt University at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis, Cerebral Lesion
What is being tested?
motor entrainment to auditory cues and music during walking on quality of movement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
2 sitesBelgium
Study dates
9 Nov 2020to 21 Feb 2025
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • diagnosis of Multiple sclerosis >1 year,
  • type of lesions: cerebellar lesions,
  • walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted).

Who cannot join

  • relapse 3 months prior to enrollment,
  • cognitive impairment impeding understanding of instructions,
  • beat amusia,
  • deafness,
  • pregnancy

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • National MS Center Melsbroek

    Melsbroek

  • Noorderhart Revalidatie & MS centrum

    Overpelt, 3900

Other trials in Belgium

About this study

Official title: Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Percieved Fatigue in Persons With Multiple Sclerosis With Cerebellar Lesions

This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Being tested
motor entrainment to auditory cues and music during walking on quality of movement
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • motor entrainment to auditory cues and music during walking on quality of movementOther

    The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Study groups in NCT04639401
Study groupRoleWhat they receive
persons with Multiple SclerosisExperimentalNot described
Receives: Other: motor entrainment to auditory cues and music during walking on quality of movement
Healthy controlsPlacebo comparatorNot described
Receives: Other: motor entrainment to auditory cues and music during walking on quality of movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resultant Vector Length

    synchronisation consistency

    Measured: week 3

  2. Resultant Vector Length

    synchronisation consistency

    Measured: week 4

  3. Resultant Vector Length

    synchronisation consistency

    Measured: week 5

  4. Relative phase angle

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

    Measured: week 3

  5. Relative phase angle

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

    Measured: week 4

  6. Relative phase angle

    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

    Measured: week 5

  7. Perceptual tempo and rhythm judgements

    subjective indications in regards to what the participants hear in terms

    Measured: week 2

  8. Asynchrony

    timing difference between the tap and the beat

    Measured: week2

  9. EEG

    64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment

    Measured: week 2

  10. Muscle weakness

    Motricity Index of dorsi flexors, knee extensors and hip flexors -

    Measured: week 1

  11. Spasticity

    Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

    Measured: week 1

  12. Ataxia

    Scale for the assessment and rating of ataxia

    Measured: week 1

  13. Dynamic gait index

    dynamic balance

    Measured: week 1

  14. Time up and Go test

    balance

    Measured: week 1

  15. 6 minute walking test

    gait pattern and endurance

    Measured: week 1

  16. Brief repeatable battery of Rao

    cognitive test

    Measured: week 1

  17. Symbol digit mobility test

    cognitive test

    Measured: week 1

  18. Stroop test 0

    cognitive test

    Measured: week 1

  19. MS walking scale -12

    impact of MS on walking ability

    Measured: week 1

  20. Activities-specific balance confidence scale

    rating of balance confidence in performing activities of daily life

    Measured: week 1

  21. Modified fatigue impact scale

    effect of fatigue

    Measured: week 1

  22. Hospital Anxiety and Depression Scale

    determine the levels of anxiety and depression

    Measured: week 1

  23. Dual task questionnaire

    troubles a person have when performing a dual task during daily activity

    Measured: week 1

Secondary outcomes (21)

  1. Cadence

    number of steps per minute

    Measured: week 3

  2. Cadence

    number of steps per minute

    Measured: week 4

  3. Cadence

    number of steps per minute

    Measured: week 5

  4. Stride length

    distance between consecutive steps (cm)

    Measured: week 3

  5. Stride length

    distance between consecutive steps (cm)

    Measured: week 4

  6. Stride length

    distance between consecutive steps (cm)

    Measured: week 5

  7. speed

    gait velocity (m/s)

    Measured: week 3

  8. speed

    gait velocity (m/s)

    Measured: week 4

  9. speed

    gait velocity (m/s)

    Measured: week 5

  10. Double Support

    time that both legs are in contact with the floor (mseconds)

    Measured: week 3

  11. Double Support

    time that both legs are in contact with the floor (mseconds)

    Measured: week 4

  12. Double Support

    time that both legs are in contact with the floor (mseconds)

    Measured: week 5

  13. Perceived cognitive and physical fatigue

    A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions

    Measured: week 3

  14. Perceived cognitive and physical fatigue

    A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions

    Measured: week 4

  15. Perceived cognitive and physical fatigue

    A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions

    Measured: week 5

  16. Perceived motivation

    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

    Measured: week 3

  17. Perceived motivation

    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

    Measured: week 4

  18. Perceived motivation

    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

    Measured: week 5

  19. Perceived walking speed

    A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions

    Measured: week 3

  20. Perceived walking speed

    A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions

    Measured: week 4

  21. Perceived walking speed

    A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions

    Measured: week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start9 Nov 2020
  3. Primary completion1 Jan 2025
  4. Study completion21 Feb 2025

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04639401
Sponsor's protocol ID
AMCiMS-001
Status last verified
Apr 2024
First submitted
9 Nov 2020
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baliviera E, Rosso M, Moens B, Poncelet M, Manto M, Cabaraux P, Van Wijmeersch B, Leman M, Feys P, Moumdjian L. Neural and behavioral entrainment to auditory rhythmic perturbations in persons with cerebellar impairment. Cereb Cortex. 2025 Jul 1;35(7):bhaf164. doi: 10.1093/cercor/bhaf164.

    PubMed 40663646

Questions about this trial

What is this clinical trial studying?

A study testing motor entrainment to auditory cues and music during walking on quality of movement in people with Multiple Sclerosis and Cerebral Lesion, run by Hasselt University at 2 sites in Belgium.

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 3 inclusion and 5 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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. Some participants in this study may receive a placebo. 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?

Resultant Vector Length (time frame: week 3). The study lists 23 primary outcomes in all. 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 NCT04639401, which also lists 1 linked publication.

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 27 Feb 2025.

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