Multiple SclerosisNCT03931278
Sonification Embodied Associations
A study testing learning and recall of a sequence of body movements in people with Multiple Sclerosis, run by Hasselt University at 3 sites in Belgium.
Trial summary
The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- learning and recall of a sequence of body movements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesBelgium
- Study dates
- 18 Dec 2018to 24 Jan 2020
- 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
- Time up and Go (TUG) test: 8 sec -- > 21 sec
Who cannot join
- cognitive impairment hindering the understanding and execution of the experimental procedures,
- pregnancy,
- hearing impairment,
- amusia
- beat deafness,
- colour blindness.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University Ghent
Ghent, 9000
National MS Center Melsbroek
Melsbroek, 1820
Revalidatie en MS Centrum Overpelt
Overpelt, 3900
About this study
Official title: Investigating Auditory Sonification (Melodic and Single Tones) and Visual Real-time Feedback as a Tool for Embodied Associations, and Its Effects on Learning and Balance in Persons With Multiple Sclerosis
The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls
- Conditions
- Multiple Sclerosis
- Being tested
- learning and recall of a sequence of body movements
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learning and recall of a sequence of body movementsOther
The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons
| Study group | Role | What they receive |
|---|---|---|
| persons with Multiple Sclerosis (MS) | Other | Not described Receives: Other: learning and recall of a sequence of body movements |
| Healthy controls | Other | Not described Receives: Other: learning and recall of a sequence of body movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
Measured: week 1
precision
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
Measured: week 1
Secondary outcomes (3)
Inter Step intervals
The technology used can log time data. Therefore, the inter-step intervals can be calculated from the logged data.
Measured: week 1
Inter Stride intervals
The technology used can log time data. Therefore, the inter stride intervals can be calculated from the logged data.
Measured: week 1
step duration on the tile
The technology used can log time data. Therefore, the total time that each foot is placed on the tiles can be derived.
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start18 Dec 2018
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- peter Feys, prof. dr., Principal investigator, Hasselt Universitylousin Moumdjian, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931278
- Sponsor's protocol ID
- SEA-001
- Status last verified
- May 2020
- First submitted
- 25 Apr 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Auditory Sonification (Melodic and Single Tones) and Visual Real-time Feedback as a Tool for Embodied Associations, and Its Effects on Learning and Balance in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03931278
- Acronym / sponsor ID
- SEA-001
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Ghent, Revalidatie & MS Centrum Overpelt, National MS Center Melsbroek
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 30 Apr 2019 (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.
The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls
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 Multiple Sclerosis (MS) | Other | Other: learning and recall of a sequence of body movements |
| Healthy controls | Other | Other: learning and recall of a sequence of body movements |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Time up and Go (TUG) test: 8 sec -- > 21 sec
Key exclusion criteria (6 listed)
- cognitive impairment hindering the understanding and execution of the experimental procedures,
- pregnancy,
- hearing impairment,
- amusia
- beat deafness,
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 |
|---|---|---|
| learning and recall of a sequence of body movementsThe objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons | Other | Healthy controls, persons with Multiple Sclerosis (MS) |
Primary outcome
accuracy
Time frame: week 1
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
precision
Time frame: week 1
Number of correct sequences uttered, total number of sequences, precisions prior to completing three correct trials.
3 secondary outcomes
Inter Step intervals
Time frame: week 1
Inter Stride intervals
Time frame: week 1
step duration on the tile
Time frame: week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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 study chair
Hasselt University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learning and recall of a sequence of body movements in people with Multiple Sclerosis, run by Hasselt University at 3 sites 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.