Healthy Volunteer, Multiple Sclerosis
Conditions
Keywords
rehabilitation, multiple sclerosis, motor control, cortical plasticity
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.
Interventions
None listed
Sponsors
Università degli Studi of Genova
University of Milan
Fondazione Don Carlo Gnocchi Onlus
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortical activation with Functional Infrared Spettroscopy (fNIRS) | Baseline | fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions. |
| Head and trunk movements quantified with Inertial Measurement Units (IMU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12) | Baseline | 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. |
| Beck Depression Inventory (BDI-II) | Baseline | To monitor anxiety and depression. The score ranges from 0 to 63, with higher scores indicating a higher degree of depression. |
| Modified Fatigue Impact Scale (MFIS) | Baseline | 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. |
| 10 Meters walking test | Baseline | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | Baseline | The EDSS is a widely used scale for measuring the level of disability in individuals with multiple sclerosis (MS). Developed by Kurtzke in 1955, it assesses both the severity of neurological impairment and the degree of disability in various functional systems. The score ranges from 0 to 10, with higher scores indicating a higher degree of disability. |
Countries
Italy
Outcome results
None listed