Cerebral Reorganizations Induced by Spinal Cord Injury Spinal Cord Injury: Multimodal Assessments of Sensory-motor and Cognitive-behavioral Functions. SUPRASPINAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete
Experimental: Patients spinal cord injury with incomplete sensorimotor deficits (ASIA B, C, D) and with complete sensorimotor deficits (ASIA A)
干预措施: MRI (Diagnostic Test)
Patients spinal cord injury with incomplete sensorimotor deficits ( ASIA B, C, D) and with complete
Experimental: Patients spinal cord injury with incomplete sensorimotor deficits (ASIA B, C, D) and with complete sensorimotor deficits (ASIA A)
干预措施: Neuropsychological tests (Behavioral)
Healthy control group
MRI : anatomical (3DT1, 3D-FLAIR), functional (task-based and resting-state) and tractographic (multiband diffusion imaging). MRI will be done once for the healthy volunteer control group.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Sensory-motor and cognitive-behavioural impact at supra-spinal level on multimodal Magnetic Resonance Imaging (MRI)
时间窗: From enrollment to the end of follow up at 12 months
The difference in task-based functional supraspinal activation pattern evolution (delta beta, GLM) between patient groups (ASIA B,C,D vs. ASIA E) quantified by the students T-score (corrected for multiple comparison) that is associated to the variability of blood flow between the active (participant performs a task in the MRI) and resting (participant is at rest in the MRI) periods. The activity pattern is described by the size (number of voxels) and localization of activated regions.
次要结局
- MADRS: Montgomery-Åsberg depression rating scale(From inclusion to the last study visit at 12 months)
- Beck Depression Inventory (BDI)(From inclusion to the last study visit at 12 months)
- Cortical volume in mm3(From enrollment to the end of follow up at 12 months)
- Difference in evolution of functional motor patterns(From enrollment to the end of follow up at 12 months)
- Montreal Cognitive Assessment score(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)(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)(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).(From enrollment to the end of follow up at 12 months)
- Difference in anatomical connectivity(From inclusion to the last study visit at 12 months)
- Measurement of cognitive-behavioral performance by MoCA test(From inclusion to the last study visit at 12 months)
- Measurement of quality of life by SF-36(From inclusion to the last study visit at 12 months)