Clinical trial NCT06826638: Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises
Official title: Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Healthy Volunteer
Keywords: rehabilitation
multiple sclerosis
motor control
cortical plasticity
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Università degli Studi of Genova
name: University of Milan
First posted: 2025-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


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.

Primary outcomes:
measure: Head and trunk movements quantified with Inertial Measurement Units (IMU)
timeFrame: Baseline
measure: Cortical activation with Functional Infrared Spettroscopy (fNIRS)
timeFrame: Baseline
Secondary outcomes:
measure: 10 Meters walking test
timeFrame: Baseline
measure: Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)
timeFrame: Baseline
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
Other outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline
Locations:
city: Genova
country: Italy
facility: Università di Genova
city: Milan
country: Italy
facility: IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi
city: Milan
country: Italy
facility: Università degli Studi di Milano
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.