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Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

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ClinicalTrials.gov Identifier: NCT04639401
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborators:
National MS Center Melsbroek
Revalidatie & MS Centrum Overpelt
Information provided by (Responsible Party):
Peter Feys, Hasselt University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Cerebral Lesion Other: motor entrainment to auditory cues and music during walking on quality of movement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: persons with Multiple Sclerosis Other: motor entrainment to auditory cues and music during walking on quality of movement
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.
Placebo Comparator: Healthy controls Other: motor entrainment to auditory cues and music during walking on quality of movement
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.


Outcome Measures
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Primary Outcome Measures :
  1. Resultant Vector Length [ Time Frame: week 3 ]
    synchronisation consistency

  2. Resultant Vector Length [ Time Frame: week 4 ]
    synchronisation consistency

  3. Resultant Vector Length [ Time Frame: week 5 ]
    synchronisation consistency

  4. Relative phase angle [ Time Frame: week 3 ]
    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  5. Relative phase angle [ Time Frame: week 4 ]
    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  6. Relative phase angle [ Time Frame: week 5 ]
    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

  7. Perceptual tempo and rhythm judgements [ Time Frame: week 2 ]
    subjective indications in regards to what the participants hear in terms

  8. Asynchrony [ Time Frame: week2 ]
    timing difference between the tap and the beat

  9. EEG [ Time Frame: week 2 ]
    64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment

  10. Muscle weakness [ Time Frame: week 1 ]
    Motricity Index of dorsi flexors, knee extensors and hip flexors -

  11. Spasticity [ Time Frame: week 1 ]
    Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

  12. Ataxia [ Time Frame: week 1 ]
    Scale for the assessment and rating of ataxia

  13. Dynamic gait index [ Time Frame: week 1 ]
    dynamic balance

  14. Time up and Go test [ Time Frame: week 1 ]
    balance

  15. 6 minute walking test [ Time Frame: week 1 ]
    gait pattern and endurance

  16. Brief repeatable battery of Rao [ Time Frame: week 1 ]
    cognitive test

  17. Symbol digit mobility test [ Time Frame: week 1 ]
    cognitive test

  18. Stroop test 0 [ Time Frame: week 1 ]
    cognitive test

  19. MS walking scale -12 [ Time Frame: week 1 ]
    impact of MS on walking ability

  20. Activities-specific balance confidence scale [ Time Frame: week 1 ]
    rating of balance confidence in performing activities of daily life

  21. Modified fatigue impact scale [ Time Frame: week 1 ]
    effect of fatigue

  22. Hospital Anxiety and Depression Scale [ Time Frame: week 1 ]
    determine the levels of anxiety and depression

  23. Dual task questionnaire [ Time Frame: week 1 ]
    troubles a person have when performing a dual task during daily activity


Secondary Outcome Measures :
  1. Cadence [ Time Frame: week 3 ]
    number of steps per minute

  2. Cadence [ Time Frame: week 4 ]
    number of steps per minute

  3. Cadence [ Time Frame: week 5 ]
    number of steps per minute

  4. Stride length [ Time Frame: week 3 ]
    distance between consecutive steps (cm)

  5. Stride length [ Time Frame: week 4 ]
    distance between consecutive steps (cm)

  6. Stride length [ Time Frame: week 5 ]
    distance between consecutive steps (cm)

  7. speed [ Time Frame: week 3 ]
    gait velocity (m/s)

  8. speed [ Time Frame: week 4 ]
    gait velocity (m/s)

  9. speed [ Time Frame: week 5 ]
    gait velocity (m/s)

  10. Double Support [ Time Frame: week 3 ]
    time that both legs are in contact with the floor (mseconds)

  11. Double Support [ Time Frame: week 4 ]
    time that both legs are in contact with the floor (mseconds)

  12. Double Support [ Time Frame: week 5 ]
    time that both legs are in contact with the floor (mseconds)

  13. Perceived cognitive and physical fatigue [ Time Frame: week 3 ]
    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

  14. Perceived cognitive and physical fatigue [ Time Frame: week 4 ]
    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

  15. Perceived cognitive and physical fatigue [ Time Frame: week 5 ]
    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

  16. Perceived motivation [ Time Frame: week 3 ]
    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

  17. Perceived motivation [ Time Frame: week 4 ]
    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

  18. Perceived motivation [ Time Frame: week 5 ]
    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

  19. Perceived walking speed [ Time Frame: week 3 ]
    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

  20. Perceived walking speed [ Time Frame: week 4 ]
    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

  21. Perceived walking speed [ Time Frame: week 5 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • relapse 3 months prior to enrollment,
  • cognitive impairment impeding understanding of instructions,
  • beat amusia,
  • deafness,
  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639401


Contacts
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Contact: Peter Feys, prof. dr. +32 11 29 21 23 peter.feys@uhasselt.be
Contact: Lousin moumdjian +32 11 26 93 71 lousin.moumdjian@uhasselt.be

Locations
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Belgium
National MS Center Melsbroek Recruiting
Melsbroek, Belgium
Contact: Lousin moumdjian, dr.    +32 11 26 93 71    lousine.moumdjian@uhasselt.be   
Contact: Johan Van Nieuwenhoven    +32 03 597 80 42      
Noorderhart Revalidatie & MS centrum Recruiting
Overpelt, Belgium, 3900
Contact: Lousin moumdjian, dr.    +32 11 26 93 71    lousine.moumdjian@uhasselt.be   
Contact: Ilse Lamers, dr.    +32 11 28 69 39    ilse.lamers@uhasselt.be   
Sub-Investigator: Ilse Bosmans         
Sub-Investigator: Ilse Lamers, dr.         
Sponsors and Collaborators
Hasselt University
National MS Center Melsbroek
Revalidatie & MS Centrum Overpelt
Investigators
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Principal Investigator: Peter Feys, prof. dr. Hasselt University
Study Chair: Lousin Moumdjian, dr. Hasselt University
More Information
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Responsible Party: Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04639401    
Other Study ID Numbers: AMCiMS-001
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases