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Набор скоро начнётся NCT07568353

Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)

Без фазы С лечением Low Back Pain Healthy

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
В протоколе указаны: Perceptive Surface (SU-PER mat).
Кому может быть актуально
Состояния в реестре: Low Back Pain, Healthy. Базовые параметры: 18 лет — 45 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

Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato

Обзор

Rationale: Chronic Low Back Pain (CLBP) is often associated with "cortical reorganization," where the brain's map of the back becomes less precise. This phenomenon contributes to the persistence of pain and reduced body awareness. While traditional rehabilitation focuses on the physical structure of the spine, neurocognitive approaches use "perceptive surfaces" to provide specific tactile and proprioceptive feedback, aiming to "retrain" the brain's representation of the trunk. Objective and Hypothesis: The primary goal of this study is to investigate how the brain responds to stimulation from these perceptive surfaces in patients with CLBP compared to healthy individuals. The investigators hypothesize that using these surfaces will lead to immediate changes in functional brain connectivity, particularly in areas responsible for body awareness and pain processing (somatosensory and salience networks). Study Procedures: The study will involve 20 patients with chronic non-specific low back pain and 20 healthy volunteers. All participants will undergo a Functional Magnetic Resonance Imaging (fMRI) session. During the scan, participants will be placed on a specialized perceptive surface. Brain activity and connectivity will be measured at rest and during specific tactile stimulation. Additionally, advanced imaging techniques (SANDI model) will be used to look at the microscopic structure of brain cells (neurons). Clinical Impact: By comparing the two groups, the study aims to identify specific "brain signatures" of recovery. This could help clinical professionals understand if perceptive surfaces can effectively restore cortical maps, leading to better personalized rehabilitation strategies for chronic pain.

Вмешательства

  • Устройство Perceptive Surface (SU-PER mat)
    The intervention consists of a postural mat equipped with sensory cones of varying elastic memory and elasticity. This tool is used as a neurocognitive rehabilitation device designed to restore body perception and postural control. The device is passive, non-magnetic, and made of MRI-compatible latex (inert material). During the fMRI session, the surface is positioned so that the participant, while lying in the scanner, perceives specific plantar or trunk tactile and proprioceptive stimuli.

Первичные конечные точки

  • Functional Connectivity Changes in Somatosensory and Salience Networks [Срок оценки: Periprocedural]
Вторичные конечные точки (3)
  • Neuronal Microstructure Mapping (SANDI model) [Срок оценки: Periprocedural]
  • Acute Pain Perception (Visual Analogue Scale) [Срок оценки: Day 1]
  • Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire) [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Aged between 18 and 45 years
  • Right-handed dominance
  • Good general health condition
  • Ability to provide written informed consent.

For the patient group:

\- Clinical diagnosis of non-specific chronic low back pain with a duration of more than 3 months

For the control group:

\- Healthy volunteers without a history of chronic pain

Критерии исключения

  • Contraindications to 3T Magnetic Resonance Imaging, such as pacemakers or non-compatible metallic implants
  • Pregnancy or breastfeeding
  • Presence of significant neurological or psychiatric pathologies
  • Current use of psychoactive medications.
  • Sensory or motor disorders of the lower limbs that prevent interaction with the perceptive surface.
  • Unstable or acute clinical conditions.
  • Inability to remain still during the MRI scanning procedure

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Италия · 1 центр
  • ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio" — Chieti

Идентификаторы

NCT: NCT07568353 · SUPER-RMNf · 447

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗