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Effect of Variance on Error Correction During Coupling

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ClinicalTrials.gov Identifier: NCT04856384
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
National MS Center Melsbroek
Revalidatie & MS Centrum Overpelt
Information provided by (Responsible Party):
Peter Feys, Hasselt University

Brief Summary:
This study is a case-control study, involving persons with progressive multiple sclerosis and healthy controls. The study contains 1 descriptive and 3 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, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Progressive Multiple Sclerosis Other: synchronisation abilities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Multiple Sclerosis With Progressive Subtypes.
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: persons with Multiple Sclerosis Other: synchronisation abilities
The study contains 1 descriptive and 3 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, with period and phase auditory manipulations

Experimental: Healthy controls Other: synchronisation abilities
The study contains 1 descriptive and 3 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, with period and phase auditory manipulations




Primary Outcome Measures :
  1. Motricity Index of dorsi flexors, knee extensors and hip flexors [ Time Frame: baseline ]
    Muscle weakness

  2. Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts [ Time Frame: baseline ]
    Spasticity

  3. Scale for the assessment and rating of ataxia [ Time Frame: Baseline ]
    ataxia

  4. Dynamic gait index [ Time Frame: Baseline ]
    dynamic balance

  5. Time up and Go test [ Time Frame: Baseline ]
    Balance

  6. 6 minute walking test [ Time Frame: Baseline ]
    gait pattern and endurance

  7. Brief repeatable battery of Rao [ Time Frame: Baseline ]
    cognitive test

  8. Symbol digit mobility test [ Time Frame: Baseline ]
    cognitive test

  9. Stroop test 0 [ Time Frame: Baseline ]
    cognitive test

  10. MS walking scale -12 [ Time Frame: Baseline ]
    impact of MS on walking ability

  11. Activities-specific balance confidence scale [ Time Frame: Baseline ]
    rating of balance confidence in performing activities of daily life

  12. Modified fatigue impact scale [ Time Frame: baseline ]
    effect of fatigue

  13. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    determine the levels of anxiety and depression

  14. Dual task questionnaire [ Time Frame: Baseline ]
    troubles a person have when performing a dual task during daily activity

  15. Perceptual tempo and rhythm judgements [ Time Frame: week 1 ]
    subjective indications in regards to what the participants hear in terms

  16. Asynchrony [ Time Frame: week 1 ]
    timing difference between the tap and the beat

  17. 64 channel EEG measurement [ Time Frame: week 1 ]
    neural correlates of entrainment

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

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

  20. Relative phase angle [ Time Frame: week 2 ]
    asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

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


Secondary Outcome Measures :
  1. Cadencce [ Time Frame: week 2 ]
    number of steps per minute

  2. Cadencce [ Time Frame: week 3 ]
    number of steps per minute

  3. Stride length [ Time Frame: week 2 ]
    distance between consecutive steps (cm)

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

  5. Speed [ Time Frame: week 2 ]
    gait velocity (m/s)

  6. Speed [ Time Frame: week 3 ]
    gait velocity (m/s)

  7. Double Support [ Time Frame: week 2 ]
    time that both legs are in contact with the floor (mseconds)

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

  9. Perceived cognitive and physical fatigue [ Time Frame: week 2 ]
    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

  10. 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

  11. Perceived motivation [ Time Frame: week 2 ]
    A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions

  12. 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

  13. Perceived walking speed [ Time Frame: week 2 ]
    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

  14. 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

  15. 64 channel EEG measurement (only conducted in 4 PwMS and HC) [ Time Frame: week 2 ]
    Neural correlates of entrainment

  16. 64 channel EEG measurement (only conducted in 4 PwMS and HC) [ Time Frame: week 3 ]
    Neural correlates of entrainment



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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, diagnosis of progressive MS,
  • 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

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): NCT04856384


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

Locations
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Belgium
National MS Center Melsbroek Recruiting
Melsbroek, Belgium, 1820
Contact: Johan Van Nieuwenhoven       johan.vannieuwenhoven@mscenter.be   
Contact: Daphne Kos, dr.    +32 3 597 80 42    daphne.kos@mscenter.be   
Principal Investigator: Johan Van Nieuwenhoven         
Noorderhart Revalidatie & MS centrum Recruiting
Overpelt, Belgium, 3900
Contact: Ilse Bosmans       ilse.bosmans@noorderhart.be   
Contact: Ilse Lamers, dr.    +32 11 28 69 39    ilse.lamers@uhasselt.be   
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
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Responsible Party: Peter Feys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04856384    
Other Study ID Numbers: MS-Music-LM-001
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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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
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases