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

NCT06826638 | Recruiting

• 1 other identifier: 2022/R-Multi/021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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

Keywords

rehabilitation; multiple sclerosis; motor control; cortical plasticity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (4)

• 10 Meters walking test

  Baseline

• Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)

  Baseline

• Modified Fatigue Impact Scale (MFIS)

  Baseline

• Beck Depression Inventory (BDI-II)

  Baseline

Other Outcomes (1)

• Expanded Disability Status Scale (EDSS)

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Università degli Studi of Genova: collaborator
• University of Milan: collaborator

Study Sites (3)

Università di Genova

Genova, 16126, Italy

RECRUITING

IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

RECRUITING

Università degli Studi di Milano

Milan, 20148, Italy

ACTIVE NOT RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 14, 2025
• Study Start: September 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)