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NCT Number: NCT06826638

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Università di Genova, Genova, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Head and trunk movements quantified with Inertial Measurement Units (IMU)

    Time frame: 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.

  2. Cortical activation with Functional Infrared Spettroscopy (fNIRS)

    Time frame: Baseline

    fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions.

Secondary outcomes

  1. 10 Meters walking test

    Time frame: 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

  2. Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)

    Time frame: 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.

  3. Modified Fatigue Impact Scale (MFIS)

    Time frame: 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.

  4. Beck Depression Inventory (BDI-II)

    Time frame: Baseline

    To monitor anxiety and depression. The score ranges from 0 to 63, with higher scores indicating a higher degree of depression.

Other outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Milan
  • Università degli Studi of Genova

Registry information

Official study title

Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks

Acronym: INSIDE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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