Unraveling Active Ingredients of Neurorehabilitation: Investigating Cortical Activity During Task-oriented Exercises

NCT ID: NCT06826638

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-07-31

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.

Conditions

Multiple Sclerosis; Healthy Volunteer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Multiple sclerosis

A sample of 20 consecutive PwMS will be recruited.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi of Genova

UNKNOWN

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Università di Genova

Genova, , Italy

Site Status: RECRUITING

IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, , Italy

Site Status: RECRUITING

Università degli Studi di Milano

Milan, , Italy

Site Status: ACTIVE_NOT_RECRUITING

Countries

Italy

Facility Contacts

Laura Bonzano, Associate Professor

Role: primary

laura.bonzano@unige.it

010 353 7040 ext. +39

Francesca Baglio, Medical Doctor - Neurologist

Role: primary

fbaglio@dongnocchi.it

0240308814 ext. +39

References

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.

Reference Type: BACKGROUND

PMID: 31469359 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16003668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32806516 (View on PubMed)

Other Identifiers

2022/R-Multi/021

Identifier Type: -

Identifier Source: org_study_id