Multiple SclerosisINSIDENCT06826638
Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises
An observational study of Multiple Sclerosis and Healthy Volunteer, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial summary
The driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session. The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Volunteer
- How many people
- 40 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Sep 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People with Multiple sclerosis people affiliated with the rehabilitation center of the IRCCS Santa Maria Nascente of the Don Gnocchi Foundation will be recruited. Participants should be able to maintain upright posture without any assistance for 30 seconds, and to walk without any assistance.
Who may be able to join
- subjects between 18 and 60 years of age,
- diagnosis of MS (McDonald criteria, Thompson et al, 2018), stable disease course without worsening more than 1 EDSS point over the last 3 months, EDSS between 3 and 4.5 points,
- healthy right-handed volunteers,
- able to release a written informed consent.
Who cannot join
- Unable to comprehend the aims of the study and to follow test instructions;
- Diagnosis of major depression (DSM-5);
- Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- Cardiovascular diseases;
- Severe visual impairments interfering with the execution of the protocol;
- epilepsy;
- intake of neuroleptic and antiepileptic drugs.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 2 recruiting
- Recruiting
Università di Genova
Genova, 16126
Laura Bonzano, Associate Professor, 010 353 7040 ext. +39, laura.bonzano@unige.it
Laura Bonzano, Associate Professor
- Recruiting
IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi
Milan, 20148
Francesca Baglio, Medical Doctor - Neurologist, 0240308814 ext. +39, fbaglio@dongnocchi.it
Francesca Baglio, Medical doctor - Neurologist
- Active, not recruiting
Università degli Studi di Milano
Milan, 20148
About this study
Official title: Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
The driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session.
The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. This would allow better understanding of cortical mechanisms underpinning functional improvements.
Read more
The project builds on preceding studies, partially funded by FISM, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. In this study, we will include 40 healthy subjects and a sample of 20 consecutive People with Multiple Sclerosis (PwMS), and we will investigate brain cortical activity during a typical session of task-oriented exercises. In specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. To study the effects of the session in improving dynamic stability, Head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fNIRS).
The first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fNIRS acquisition in PwMS. Finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and PwMS will serve to develop a model for neurological rehabilitation.
- Conditions
- Multiple Sclerosis, Healthy Volunteer
- Keywords
- rehabilitation, multiple sclerosis, motor control, cortical plasticity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | A sample of 20 consecutive PwMS will be recruited. | |
| Healthy volunteers | We will recruit a group of healthy individuals to obtain normative reference data. These individuals will be matched for sex and age with the subjects having multiple sclerosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head and trunk movements quantified with Inertial Measurement Units (IMU)
The following variables are calculated: (1) the angular displacements in the sagittal and frontal planes, calculated as 1 standard deviation (SD) from the angular displacement data; and the head and angular velocities, which are the root mean square of the first derivative of angular displacements in the sagittal and frontal planes.
Measured: Baseline
Cortical activation with Functional Infrared Spettroscopy (fNIRS)
fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions.
Measured: Baseline
Secondary outcomes (4)
10 Meters walking test
The 10-Meter Walking Test (10MWT) is a commonly used assessment to measure walking speed and functional mobility, especially in individuals with neurological conditions like multiple sclerosis
Measured: Baseline
Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)
to assess walking perceived ability of people with multiple sclerosis. The score ranges from 12 to 60, with higher scores indicating a higher degree of walking impairment.
Measured: Baseline
Modified Fatigue Impact Scale (MFIS)
To assess the perceived impact of fatigue in people with multiple sclerosis. The score ranges from 0 to 84, with higher scores indicating a higher degree of fatigue.
Measured: Baseline
Beck Depression Inventory (BDI-II)
To monitor anxiety and depression. The score ranges from 0 to 63, with higher scores indicating a higher degree of depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Sep 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi of Genova, University of Milan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826638
- Sponsor's protocol ID
- 2022/R-Multi/021
- Acronym
- INSIDE
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prosperini L, Di Filippo M. Beyond clinical changes: Rehabilitation-induced neuroplasticity in MS. Mult Scler. 2019 Sep;25(10):1348-1362. doi: 10.1177/1352458519846096.
PubMed 31469359Cattaneo D, Ferrarin M, Frasson W, Casiraghi A. Head control: volitional aspects of rehabilitation training in patients with multiple sclerosis compared with healthy subjects. Arch Phys Med Rehabil. 2005 Jul;86(7):1381-8. doi: 10.1016/j.apmr.2004.12.029.
PubMed 16003668Bonilauri A, Sangiuliano Intra F, Pugnetti L, Baselli G, Baglio F. A Systematic Review of Cerebral Functional Near-Infrared Spectroscopy in Chronic Neurological Diseases-Actual Applications and Future Perspectives. Diagnostics (Basel). 2020 Aug 12;10(8):581. doi: 10.3390/diagnostics10080581.
PubMed 32806516Torchio A, Mattos FGM, Bove M, Iester C, Cattaneo D, Bonzano L, Gervasoni E. Cortical and Kinematic Correlates of Feedback-Based Head Stabilization During Treadmill Walking. IEEE Trans Neural Syst Rehabil Eng. 2026;34:2024-2033. doi: 10.1109/TNSRE.2026.3683304.
PubMed 41973556
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
- ClinicalTrials.gov ID
- NCT06826638
- Acronym / sponsor ID
- INSIDE / 2022/R-Multi/021
- Conditions
- Multiple Sclerosis, Healthy Volunteer
- Keywords
- rehabilitation, multiple sclerosis, motor control, cortical plasticity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Università degli Studi of Genova, University of Milan
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 14 Feb 2025 (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 driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session.
The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. This would allow better understanding of cortical mechanisms underpinning functional improvements.
The project builds on preceding studies, partially funded by FISM, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. In this study, we will include 40 healthy subjects and a sample of 20 consecutive People with Multiple Sclerosis (PwMS), and we will investigate brain cortical activity during a typical session of task-oriented exercises. In specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. To study the effects of the session in improving dynamic stability, Head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fNIRS).
The first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fNIRS acquisition in PwMS. Finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and PwMS will serve to develop a model for neurological rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | –A sample of 20 consecutive PwMS will be recruited. |
| Healthy volunteers | – | –We will recruit a group of healthy individuals to obtain normative reference data. These individuals will be matched for sex and age with the subjects having multiple sclerosis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People with Multiple sclerosis people affiliated with the rehabilitation center of the IRCCS Santa Maria Nascente of the Don Gnocchi Foundation will be recruited. Participants should be able to maintain upright posture without any assistance for 30 seconds, and to walk without any assistance.
Key inclusion criteria (4 listed)
- subjects between 18 and 60 years of age,
- diagnosis of MS (McDonald criteria, Thompson et al, 2018), stable disease course without worsening more than 1 EDSS point over the last 3 months, EDSS between 3 and 4.5 points,
- healthy right-handed volunteers,
- able to release a written informed consent.
Key exclusion criteria (7 listed)
- Unable to comprehend the aims of the study and to follow test instructions;
- Diagnosis of major depression (DSM-5);
- Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- Cardiovascular diseases;
- Severe visual impairments interfering with the execution of the protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Head and trunk movements quantified with Inertial Measurement Units (IMU)
Time frame: Baseline
The following variables are calculated: (1) the angular displacements in the sagittal and frontal planes, calculated as 1 standard deviation (SD) from the angular displacement data; and the head and angular velocities, which are the root mean square of the first derivative of angular displacements in the sagittal and frontal planes.
Cortical activation with Functional Infrared Spettroscopy (fNIRS)
Time frame: Baseline
fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions.
4 secondary outcomes
10 Meters walking test
Time frame: Baseline
Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)
Time frame: Baseline
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline
Beck Depression Inventory (BDI-II)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 31469359Prosperini L, Di Filippo M. Beyond clinical changes: Rehabilitation-induced neuroplasticity in MS. Mult Scler. 2019 Sep;25(10):1348-1362. doi: 10.1177/1352458519846096.
- Background: PubMed 16003668Cattaneo D, Ferrarin M, Frasson W, Casiraghi A. Head control: volitional aspects of rehabilitation training in patients with multiple sclerosis compared with healthy subjects. Arch Phys Med Rehabil. 2005 Jul;86(7):1381-8. doi: 10.1016/j.apmr.2004.12.029.
- Background: PubMed 32806516Bonilauri A, Sangiuliano Intra F, Pugnetti L, Baselli G, Baglio F. A Systematic Review of Cerebral Functional Near-Infrared Spectroscopy in Chronic Neurological Diseases-Actual Applications and Future Perspectives. Diagnostics (Basel). 2020 Aug 12;10(8):581. doi: 10.3390/diagnostics10080581.
- Derived from this study: PubMed 41973556Torchio A, Mattos FGM, Bove M, Iester C, Cattaneo D, Bonzano L, Gervasoni E. Cortical and Kinematic Correlates of Feedback-Based Head Stabilization During Treadmill Walking. IEEE Trans Neural Syst Rehabil Eng. 2026;34:2024-2033. doi: 10.1109/TNSRE.2026.3683304.
- Individual participant dataSharing planned: No
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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.
IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi
Milan, Italy
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 and Healthy Volunteer, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head and trunk movements quantified with Inertial Measurement Units (IMU) (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT06826638, which also lists 4 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 14 Feb 2025.