Actively Recruiting

Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06826638

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

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-14

40

Participants Needed

3

Research Sites

99 weeks

Total Duration

On this page

Sponsors

F

Fondazione Don Carlo Gnocchi Onlus

Lead Sponsor

U

Università degli Studi of Genova

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects between 18 and 60 years of age
  • Diagnosis of Multiple Sclerosis (McDonald criteria, Thompson et al, 2018) with stable disease course and no worsening of more than 1 EDSS point over the last 3 months
  • EDSS score between 3 and 4.5 points
  • Healthy right-handed volunteers
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to understand study aims or follow test instructions
  • Diagnosis of major depression (DSM-5)
  • Severe joint or bone disorders affecting balance or gait
  • Cardiovascular diseases
  • Severe visual impairments interfering with the protocol
  • Epilepsy
  • Use of neuroleptic or antiepileptic drugs

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Università di Genova

Genova, Italy, 16126

Actively Recruiting

2

IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi

Milan, Italy, 20148

Actively Recruiting

3

Università degli Studi di Milano

Milan, Italy, 20148

Active, Not Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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