Effect of Variance on Error Correction During Coupling

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856384
• Other study ID #: MS-Music-LM-001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Hasselt University
• Contact: Peter Feys, prof. dr.
• Phone: +32 11 29 21 23
• Email: peter.feys[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Belgium	National MS Center Melsbroek	Melsbroek
Belgium	Noorderhart Revalidatie & MS centrum	Overpelt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	National MS Center Melsbroek, Noorderhart Revalidatie & MS

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	baseline
Primary	Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	baseline
Primary	Scale for the assessment and rating of ataxia	ataxia	Baseline
Primary	Dynamic gait index	dynamic balance	Baseline
Primary	Time up and Go test	Balance	Baseline
Primary	6 minute walking test	gait pattern and endurance	Baseline
Primary	Brief repeatable battery of Rao	cognitive test	Baseline
Primary	Symbol digit mobility test	cognitive test	Baseline
Primary	Stroop test 0	cognitive test	Baseline
Primary	MS walking scale -12	impact of MS on walking ability	Baseline
Primary	Activities-specific balance confidence scale	rating of balance confidence in performing activities of daily life	Baseline
Primary	Modified fatigue impact scale	effect of fatigue	baseline
Primary	Hospital Anxiety and Depression Scale	determine the levels of anxiety and depression	Baseline
Primary	Dual task questionnaire	troubles a person have when performing a dual task during daily activity	Baseline
Primary	Perceptual tempo and rhythm judgements	subjective indications in regards to what the participants hear in terms	week 1
Primary	Asynchrony	timing difference between the tap and the beat	week 1
Primary	64 channel EEG measurement	neural correlates of entrainment	week 1
Primary	Resultant Vector Length	synchronisation consistency	week 2
Primary	Resultant Vector Length	synchronisation consistency	week 3
Primary	Relative phase angle	asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)	week 2
Primary	Relative phase angle	asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)	week 3
Secondary	Cadencce	number of steps per minute	week 2
Secondary	Cadencce	number of steps per minute	week 3
Secondary	Stride length	distance between consecutive steps (cm)	week 2
Secondary	Stride length	distance between consecutive steps (cm)	week 3
Secondary	Speed	gait velocity (m/s)	week 2
Secondary	Speed	gait velocity (m/s)	week 3
Secondary	Double Support	time that both legs are in contact with the floor (mseconds)	week 2
Secondary	Double Support	time that both legs are in contact with the floor (mseconds)	week 3
Secondary	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	week 2
Secondary	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	week 3
Secondary	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	week 2
Secondary	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	week 3
Secondary	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	week 2
Secondary	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	week 3
Secondary	64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 2
Secondary	64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 3