Cerebellar LesionsNCT04887753
Effect of Variance on Error Correction During Coupling (Cerrebellar Lesions)
A study testing Synchronisation abilities in people with Cerebellar Lesions, run by Hasselt University at 1 site in Belgium.
Trial summary
This study is a case-control study, involving persons with persons with cerebellar lesions 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Lesions
- What is being tested?
- Synchronisation abilities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of cerrebellar lesions
- walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)
Who cannot join
- cognitive impairment impeding understanding of
- instructions,
- beat amusia,
- deafness,
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Civil Marie Curie
Lodelinsart, 6042
Mario Manto, prof. dr., +32 11 26 93 71, mmanto@ulb.ac.be
Pierre Cabaraux, dr., pierre.cabaraux@chu-charleroi.be
About this study
Official title: Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Cerrebellar Lesions
This study is a case-control study, involving persons with persons with cerebellar lesions 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
- Cerebellar Lesions
- Being tested
- Synchronisation abilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronisation abilitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| persons with cerebellar lesions | Experimental | Not described Receives: Other: Synchronisation abilities |
| Healthy controls | Active comparator | Not described Receives: Other: Synchronisation abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motricity Index of dorsi flexors, knee extensors and hip flexors
Muscle weakness
Measured: baseline
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Spasticity
Measured: baseline
Scale for the assessment and rating of ataxia
ataxia
Measured: baseline
Dynamic gait index
dynamic balance
Measured: baseline
Time up and Go test
Balance
Measured: baseline
6 minute walking test
gait pattern and endurance
Measured: baseline
cerebellar affective syndrome test
cognitive test
Measured: baseline
Activities-specific balance confidence scale
rating of balance confidence in performing activities of daily life
Measured: baseline
Modified fatigue impact scale
effect of fatigue
Measured: baseline
Hospital Anxiety and Depression Scale
determine the levels of anxiety and depression
Measured: baseline
Dual task questionnaire
troubles a person have when performing a dual task during daily activity
Measured: baseline
Perceptual tempo and rhythm judgements
subjective indications in regards to what the participants hear in terms
Measured: week 1
Asynchrony
timing difference between the tap and the beat
Measured: week 1
64 channel EEG measurement
neural correlates of entrainment
Measured: week 1
Resultant Vector Length
synchronisation consistency
Measured: week 1
Resultant Vector Length
synchronisation consistency
Measured: week 2
Resultant Vector Length
synchronisation consistency
Measured: week 3
Relative phase angle
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Measured: week 2
Relative phase angle
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Measured: week 3
Secondary outcomes (16)
Cadencce
number of steps per minute
Measured: week 2
Cadencce
number of steps per minute
Measured: week 3
Stride length
distance between consecutive steps (cm)
Measured: week 2
Stride length
distance between consecutive steps (cm)
Measured: week 3
Speed
gait velocity (m/s)
Measured: week 2
Speed
gait velocity (m/s)
Measured: week 3
Double Support
time that both legs are in contact with the floor (mseconds)
Measured: week 2
Double Support
time that both legs are in contact with the floor (mseconds)
Measured: week 3
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
Measured: week 2
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
Measured: week 3
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
Measured: week 2
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
Measured: week 3
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
Measured: week 2
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
Measured: week 3
64 channel EEG measurement (only conducted in 4 PwMS and HC)
Neural correlates of entrainment
Measured: week 2
64 channel EEG measurement (only conducted in 4 PwMS and HC)
Neural correlates of entrainment
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start29 Apr 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebellar LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Charleroi, Erasme University Hospital
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityLousin Moumdjian, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887753
- Sponsor's protocol ID
- CL-Music-001
- Status last verified
- Apr 2024
- First submitted
- 11 May 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baliviera E, Rosso M, Moens B, Poncelet M, Manto M, Cabaraux P, Van Wijmeersch B, Leman M, Feys P, Moumdjian L. Neural and behavioral entrainment to auditory rhythmic perturbations in persons with cerebellar impairment. Cereb Cortex. 2025 Jul 1;35(7):bhaf164. doi: 10.1093/cercor/bhaf164.
PubMed 40663646Fayyad MBN, Verbiest JR, Ivanova A, Manto M, Moumdjian L. Feature derivation and classification of auditory-motor coupling dynamics in healthy and neurologically impaired adults. PLoS One. 2024 Dec 16;19(12):e0315607. doi: 10.1371/journal.pone.0315607. eCollection 2024.
PubMed 39680529
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Cerrebellar Lesions
- ClinicalTrials.gov ID
- NCT04887753
- Acronym / sponsor ID
- CL-Music-001
- Conditions
- Cerebellar Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- CHU de Charleroi, Erasme University Hospital
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a case-control study, involving persons with persons with cerebellar lesions 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| persons with cerebellar lesions | Experimental | Other: Synchronisation abilities |
| Healthy controls | Active comparator | Other: Synchronisation abilities |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of cerrebellar lesions
- walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)
Key exclusion criteria (5 listed)
- cognitive impairment impeding understanding of
- instructions,
- beat amusia,
- deafness,
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synchronisation abilitiesThe 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. | Other | Healthy controls, persons with cerebellar lesions |
Primary outcome
Motricity Index of dorsi flexors, knee extensors and hip flexors
Time frame: baseline
Muscle weakness
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
Time frame: baseline
Spasticity
Scale for the assessment and rating of ataxia
Time frame: baseline
ataxia
Dynamic gait index
Time frame: baseline
dynamic balance
Time up and Go test
Time frame: baseline
Balance
6 minute walking test
Time frame: baseline
gait pattern and endurance
cerebellar affective syndrome test
Time frame: baseline
cognitive test
Activities-specific balance confidence scale
Time frame: baseline
rating of balance confidence in performing activities of daily life
Modified fatigue impact scale
Time frame: baseline
effect of fatigue
Hospital Anxiety and Depression Scale
Time frame: baseline
determine the levels of anxiety and depression
Dual task questionnaire
Time frame: baseline
troubles a person have when performing a dual task during daily activity
Perceptual tempo and rhythm judgements
Time frame: week 1
subjective indications in regards to what the participants hear in terms
Asynchrony
Time frame: week 1
timing difference between the tap and the beat
64 channel EEG measurement
Time frame: week 1
neural correlates of entrainment
Resultant Vector Length
Time frame: week 1
synchronisation consistency
Resultant Vector Length
Time frame: week 2
synchronisation consistency
Resultant Vector Length
Time frame: week 3
synchronisation consistency
Relative phase angle
Time frame: week 2
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Relative phase angle
Time frame: week 3
asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
16 secondary outcomes
Cadencce
Time frame: week 2
Cadencce
Time frame: week 3
Stride length
Time frame: week 2
Stride length
Time frame: week 3
Speed
Time frame: week 2
Speed
Time frame: week 3
Double Support
Time frame: week 2
Double Support
Time frame: week 3
Perceived cognitive and physical fatigue
Time frame: week 2
Perceived cognitive and physical fatigue
Time frame: week 3
Perceived motivation
Time frame: week 2
Perceived motivation
Time frame: week 3
Perceived walking speed
Time frame: week 2
Perceived walking speed
Time frame: week 3
64 channel EEG measurement (only conducted in 4 PwMS and HC)
Time frame: week 2
64 channel EEG measurement (only conducted in 4 PwMS and HC)
Time frame: week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 40663646Baliviera E, Rosso M, Moens B, Poncelet M, Manto M, Cabaraux P, Van Wijmeersch B, Leman M, Feys P, Moumdjian L. Neural and behavioral entrainment to auditory rhythmic perturbations in persons with cerebellar impairment. Cereb Cortex. 2025 Jul 1;35(7):bhaf164. doi: 10.1093/cercor/bhaf164.
- Derived from this study: PubMed 39680529Fayyad MBN, Verbiest JR, Ivanova A, Manto M, Moumdjian L. Feature derivation and classification of auditory-motor coupling dynamics in healthy and neurologically impaired adults. PLoS One. 2024 Dec 16;19(12):e0315607. doi: 10.1371/journal.pone.0315607. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, prof. dr. principal investigator
Hasselt University
Lousin Moumdjian, dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronisation abilities in people with Cerebellar Lesions, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Feys, prof. dr. (+32 11 29 21 23, peter.feys@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motricity Index of dorsi flexors, knee extensors and hip flexors (time frame: baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.