Spinal Cord Injury: Impact on Sensory, Motor, Behavioral and Cognitive Functions

Официальное название

Cerebral Reorganizations Induced by Spinal Cord Injury Spinal Cord Injury: Multimodal Assessments of Sensory-motor and Cognitive-behavioral Functions. SUPRASPINAL

Обзор

Spinal cord injury (SCI) causes a variety of sensory-motor deficits and neuropsychological consequences. Magnetic resonance imaging (MRI) reveals a reduction in the volume of the somato-sensory and motor cortices, as well as atrophy in the white matter bundles. In addition, disturbances in cerebral activity are observed in several areas, notably the motor cortex and the prefrontal cortex. The aim of this study is to understand the evolution of brain function after SCI in comparison with a control group of healthy volunteers. We distinguish between patients with incomplete sensorimotor deficits (ASIA B,C,D) and complete sensorimotor deficits (ASIA A). Both patient groups will have a multimodal assessment at 1 week, 3 months and 12 months after SCI with MRI and neuropsychological tests. The group of healthy volunteers will only perform one MRI.

Подробное описание

Lesions of the spinal cord induce sensory-motor deficits and have various neuropsychological effects. MRI shows a reduction in the volume of the somatosensory and motor cortices, as well as atrophy of the white matter bundles.

Disturbances in brain activity are observed in several critical areas. Patients may experience cognitive impairment and an increased risk of depression and anxiety. Although deep brain stimulation and transcranial magnetic stimulation have shown positive effects, the efficacy of these treatments remains limited, partly due to insufficient understanding of post-SCI brain changes.

The cognitive and behavioral consequences of spinal cord injury are poorly understood and mainly treated by symptomatic therapies, which are often ineffective and may have side effects.

A better understanding of brain networks and their plasticity after spinal cord injury could facilitate the development of targeted therapies, such as cortical or deep basal ganglia stimulation.

Вмешательства

• Диагностический тест MRI
  MRI : anatomical (3DT1, 3D-FLAIR), functional (task-based and resting-state) and tractographic (multiband diffusion imaging) at three time points: one week, three months and twelve months after the spinal cord injury (SCI)
• Поведенческое Neuropsychological tests
  The following tests will be performed: the Montreal Cognitive Assessment (MOCA), the Montgomery-Åsberg depression rating scale (MADRS), the Medical Outcome Study Short Form 36 (SF-36)

Первичные конечные точки

• Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI) [Срок оценки: From enrollment to the end of follow up at 12 months]

Вторичные конечные точки (11)

• Cortical volume in mm3 [Срок оценки: From enrollment to the end of follow up at 12 months]
• Difference in evolution of functional motor patterns [Срок оценки: From enrollment to the end of follow up at 12 months]
• Montreal Cognitive Assessment score [Срок оценки: From enrollment to the end of follow up at 12 months]
• Difference in local resting-state connectivity (ALFF) between groups, quantified by the student T-score (corrected for multiple comparisons) [Срок оценки: From enrollment to the end of follow up at 12 months]
• Difference in local resting-state connectivity (ReHo) between groups, quantified by the student T-score (corrected for multiple comparisons) [Срок оценки: From enrollment to the end of follow up at 12 months]
• Difference in global resting-state connectivity (global efficiency - theory des graphs) between groups, quantified by the student T-score (corrected for multiple comparisons). [Срок оценки: From enrollment to the end of follow up at 12 months]
• Difference in anatomical connectivity [Срок оценки: From inclusion to the last study visit at 12 months]
• Measurement of cognitive-behavioral performance by MoCA test [Срок оценки: From inclusion to the last study visit at 12 months]
• Measurement of quality of life by SF-36 [Срок оценки: From inclusion to the last study visit at 12 months]
• Beck Depression Inventory (BDI) [Срок оценки: From inclusion to the last study visit at 12 months]
• MADRS: Montgomery-Åsberg depression rating scale [Срок оценки: From inclusion to the last study visit at 12 months]

Критерии участия

Критерии включения

• adults aged 18 to 80
• informed consent
• patient with MCT in the previous week
• clinical neurological examination demonstrating a sensory-motor deficit (the severity of which will define the group to which the patient belongs) associated with MCT.

Критерии исключения

• Impossibility of following the patient during the study period
• Consent not obtained (adults, non-emancipated minors, persons unable to give consent, research carried out in emergency situations, etc.),
• Not affiliated to a social security scheme,
• Persons under court protection,
• Other life-threatening systemic impairment,
• Prior cognitive impairment,
• Contraindication to MRI (pacemaker, metallic foreign body, etc.).

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

Диагностика

Центры проведения

Франция · 1 центр

• CHU de Montpellier — Montpellier

Идентификаторы

NCT: NCT06887309 · RECHMPL23_0434 · 2024-A00206-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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