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Идёт набор NCT06826638

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

— Наблюдательное Multiple Sclerosis Healthy Volunteer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Healthy Volunteer. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Head and trunk movements quantified with Inertial Measurement Units (IMU) [Срок оценки: Baseline]
  • Cortical activation with Functional Infrared Spettroscopy (fNIRS) [Срок оценки: Baseline]
Вторичные конечные точки (4)
  • 10 Meters walking test [Срок оценки: Baseline]
  • Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12) [Срок оценки: Baseline]
  • Modified Fatigue Impact Scale (MFIS) [Срок оценки: Baseline]
  • Beck Depression Inventory (BDI-II) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 3 центра
  • Università di Genova — Genova
  • IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi — Milan
  • Università degli Studi di Milano — Milan

Публикации

  • 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
  • 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
  • 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
  • Torchio A, Mattos FGM, Bove M, Iester C, Cattaneo D, Bonzano L, Gervasoni E. Cortical and Kinematic Correlates of Feedback-Based Head Stabilization During Treadmill Walking. IEEE Trans Neural Syst Rehabil Eng. 2026;34:2024-2033. doi: 10.1109/TNSRE.2026.3683304. PMID 41973556

Идентификаторы

NCT: NCT06826638 · 2022/R-Multi/021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗