Multiple SclerosisNCT06219291
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part A
An observational study of Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial summary
Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease. Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Observational
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jul 2022to Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited within Persons with Multiple Sclerosis attending the clinical centers for routine medical visits willing to participate to the study after the presentation of the information sheet.
Who may be able to join
- Age > 17 years
- Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
- Expanded Disability Status Scale (EDSS) <2.5
Who cannot join
- Major depression
- Mini-Mental State Examination < 27
- Other cardiovascular or orthopedic diseases that interfere with physical exercise
- Undefined or not confirmed diagnosis of MS (Polman criteria)
- Progressive course of the disease
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Binaghi ASL Cagliari
Cagliari
IRCCS Ospedale San Raffele
Milan, 20100
IRCCS Fondazione Don Carlo Gnocchi
Milan, 20148
About this study
Official title: Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part A
Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease.
Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS.
Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.
- Conditions
- Multiple Sclerosis
- Being tested
- Observational
- Keywords
- early phase, non-disabled
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observation of the natural course of the disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk test (SMWT)
Assesses distance in meters walked over 6 minutes as a sub-maximal test of endurance capacity.
Measured: Baseline, Follow-up 1year, Follow-up 2year
Secondary outcomes (3)
Concentration of oxygenated hemoglobin (Delta oxyHb)
The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.
Measured: Baseline, Follow-up 1year, Follow-up 2year
Expanded Disability Status Scale (EDSS)
Assess the neurological impairment as a result of Multiple Sclerosis, ranging from 0 (normal neurological exam) to 10 (death due to Multiple Sclerosis).
Measured: Baseline, Follow up 1year, Follow up 2year
Regularity of gait
Instrumental gait indexes will be extracted from an Inertial Measurement Unit (IMU) during the a walking test.
Measured: Baseline, Follow-up 1year, Follow-up 2yearr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jul 2022
- Primary completion7 Jul 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
- Responsible party
- Sponsor
- Investigators
- Marco Rovaris, MD, Principal investigator, IRCCS Fondazione Don Carlo GnocchiRaffaella Chieffo, MD, Principal investigator, IRCCS Ospedale San RaffaeleEleonora Cocco, MD, Principal investigator, Ospedale Binaghi ASL Cagliari, Sardegna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219291
- Sponsor's protocol ID
- 03_17/02/2021 Part A
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gervasoni E, Torchio A, Bertoni R, Chieffo R, Rocca MA, Pau M, Cocco E, Morozumi T, Filippi M, Cattaneo D, Rovaris M. Beyond EDSS: multidomain impairments are detectable and associated with walking disorders in low-disabled people with multiple sclerosis. J Neurol. 2025 May 18;272(6):404. doi: 10.1007/s00415-025-13128-7.
PubMed 40382461
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part A
- ClinicalTrials.gov ID
- NCT06219291
- Acronym / sponsor ID
- 03_17/02/2021 Part A
- Conditions
- Multiple Sclerosis
- Keywords
- early phase, non-disabled
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 7 Jul 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (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.
Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease.
Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS.
Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited within Persons with Multiple Sclerosis attending the clinical centers for routine medical visits willing to participate to the study after the presentation of the information sheet.
Key inclusion criteria (3 listed)
- Age > 17 years
- Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
- Expanded Disability Status Scale (EDSS) <2.5
Key exclusion criteria (5 listed)
- Major depression
- Mini-Mental State Examination < 27
- Other cardiovascular or orthopedic diseases that interfere with physical exercise
- Undefined or not confirmed diagnosis of MS (Polman criteria)
- Progressive course of the disease
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 |
|---|---|---|
| ObservationalObservation of the natural course of the disease | Other | – |
Primary outcome
Six Minute Walk test (SMWT)
Time frame: Baseline, Follow-up 1year, Follow-up 2year
Assesses distance in meters walked over 6 minutes as a sub-maximal test of endurance capacity.
3 secondary outcomes
Concentration of oxygenated hemoglobin (Delta oxyHb)
Time frame: Baseline, Follow-up 1year, Follow-up 2year
Expanded Disability Status Scale (EDSS)
Time frame: Baseline, Follow up 1year, Follow up 2year
Regularity of gait
Time frame: Baseline, Follow-up 1year, Follow-up 2yearr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 40382461Gervasoni E, Torchio A, Bertoni R, Chieffo R, Rocca MA, Pau M, Cocco E, Morozumi T, Filippi M, Cattaneo D, Rovaris M. Beyond EDSS: multidomain impairments are detectable and associated with walking disorders in low-disabled people with multiple sclerosis. J Neurol. 2025 May 18;272(6):404. doi: 10.1007/s00415-025-13128-7.
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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.
Marco Rovaris, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi
Raffaella Chieffo, MD principal investigator
IRCCS Ospedale San Raffaele
Eleonora Cocco, MD principal investigator
Ospedale Binaghi ASL Cagliari, Sardegna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
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 3 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 23 Jan 2024. 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 Italy. 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?
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?
Six Minute Walk test (SMWT) (time frame: Baseline, Follow-up 1year, Follow-up 2year). 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 NCT06219291, which also lists 1 linked publication.
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 23 Jan 2024.