Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Healthy Volunteer. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
Overview
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.
Primary outcome measures
- Head and trunk movements quantified with Inertial Measurement Units (IMU) [Time frame: Baseline]
- Cortical activation with Functional Infrared Spettroscopy (fNIRS) [Time frame: Baseline]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 3 centers
- Università di Genova — Genova
- IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi — Milan
- Università degli Studi di Milano — Milan
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. PMID 31469359
- Cattaneo 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. PMID 16003668
- Bonilauri 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. PMID 32806516
- Torchio 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. PMID 41973556
Identifiers
NCT: NCT06826638 · 2022/R-Multi/021