Effect of Variance on Error Correction During Coupling

NCT04856384 | Completed

• 1 other identifier: MS-Music-LM-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (21)

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

  Muscle weakness

  baseline

• Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

  Spasticity

  baseline

• Scale for the assessment and rating of ataxia

  ataxia

  Baseline

• Dynamic gait index

  dynamic balance

  Baseline

• Time up and Go test

  Balance

  Baseline

• 6 minute walking test

  gait pattern and endurance

  Baseline

• Brief repeatable battery of Rao

  cognitive test

  Baseline

• Symbol digit mobility test

  cognitive test

  Baseline

• Stroop test 0

  cognitive test

  Baseline

• MS walking scale -12

  impact of MS on walking ability

  Baseline

• Activities-specific balance confidence scale

  rating of balance confidence in performing activities of daily life

  Baseline

• Modified fatigue impact scale

  effect of fatigue

  baseline

• Hospital Anxiety and Depression Scale

  determine the levels of anxiety and depression

  Baseline

• Dual task questionnaire

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

  Baseline

• Perceptual tempo and rhythm judgements

  subjective indications in regards to what the participants hear in terms

  week 1

• Asynchrony

  timing difference between the tap and the beat

  week 1

• 64 channel EEG measurement

  neural correlates of entrainment

  week 1

• Resultant Vector Length

  synchronisation consistency

  week 2

• Resultant Vector Length

  synchronisation consistency

  week 3

• Relative phase angle

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

  week 2

• Relative phase angle

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

  week 3

Secondary Outcomes (16)

• Cadencce

  week 2

• Cadencce

  week 3

• Stride length

  week 2

• Stride length

  week 3

• Speed

  week 2

Study Arms (2)

persons with Multiple Sclerosis

EXPERIMENTAL

Other: synchronisation abilities

Healthy controls

EXPERIMENTAL

Other: synchronisation abilities

Interventions

synchronisation abilities OTHER

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

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, diagnosis of progressive MS,
• 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, 1820, Belgium

Location

Noorderhart Revalidatie & MS centrum

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: April 23, 2021
• Study Start: February 1, 2021
• Primary Completion: October 22, 2024
• Study Completion: December 31, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)