Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

NCT04639401 | Completed

• 1 other identifier: AMCiMS-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Cerebral Lesion

Outcome Measures

Primary Outcomes (23)

• Resultant Vector Length

  synchronisation consistency

  week 3

• Resultant Vector Length

  synchronisation consistency

  week 4

• Resultant Vector Length

  synchronisation consistency

  week 5

• Relative phase angle

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

  week 3

• Relative phase angle

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

  week 4

• Relative phase angle

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

  week 5

• Perceptual tempo and rhythm judgements

  subjective indications in regards to what the participants hear in terms

  week 2

• Asynchrony

  timing difference between the tap and the beat

  week2

• EEG

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

  week 2

• Muscle weakness

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

  week 1

• Spasticity

  Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

  week 1

• Ataxia

  Scale for the assessment and rating of ataxia

  week 1

• Dynamic gait index

  dynamic balance

  week 1

• Time up and Go test

  balance

  week 1

• 6 minute walking test

  gait pattern and endurance

  week 1

• Brief repeatable battery of Rao

  cognitive test

  week 1

• Symbol digit mobility test

  cognitive test

  week 1

• Stroop test 0

  cognitive test

  week 1

• MS walking scale -12

  impact of MS on walking ability

  week 1

• Activities-specific balance confidence scale

  rating of balance confidence in performing activities of daily life

  week 1

• Modified fatigue impact scale

  effect of fatigue

  week 1

• Hospital Anxiety and Depression Scale

  determine the levels of anxiety and depression

  week 1

• Dual task questionnaire

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

  week 1

Secondary Outcomes (21)

• Cadence

  week 3

• Cadence

  week 4

• Cadence

  week 5

• Stride length

  week 3

• Stride length

  week 4

Study Arms (2)

persons with Multiple Sclerosis

EXPERIMENTAL

Other: motor entrainment to auditory cues and music during walking on quality of movement

Healthy controls

PLACEBO COMPARATOR

Other: motor entrainment to auditory cues and music during walking on quality of movement

Interventions

motor entrainment to auditory cues and music during walking on quality of movement OTHER

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.

Healthy controls; persons with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• National MS Center Melsbroek: collaborator
• Revalidatie & MS Centrum Overpelt: collaborator

Study Sites (2)

National MS Center Melsbroek

Melsbroek, Belgium

Location

Noorderhart Revalidatie & MS centrum

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Feys, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Lousin Moumdjian, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: November 9, 2020
• Primary Completion: January 1, 2025
• Study Completion: February 21, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)