NCT05681936招募中不适用
Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Cross-sectional study: lumbosacral functional fMRI
研究概览
简要总结
Building on recent improvements, state-of-the-art functional MRI will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (SCI) patients to characterize the remaining neuronal activity of the motor and sensory neurons. Alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. Results of this study will be of crucial importance because SCI patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Informed consent
- •Willing to take part and follow requirements of the protocol
- •Patients additionally need to fulfil the following study-specific inclusion criteria:
- •Cross-sectional study:
- •Chronic traumatic SCI (> 12 months after injury) or
- •Diagnosed degenerative spondylotic myelopathy (DCM)
- •Longitudinal study:
- •Acute traumatic SCI (< 2 months after injury) or
- •Patients with neurogenic lower urinary tract dysfunction (NLUTD) who undergo routine tibial nerve stimulation (TNS) treatment as part of their rehabilitation (but independently of this study) at Balgrist University Hospital
排除标准
- •Age < 18 years
- •Contraindications for MRI (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (SCMI) guidelines and in case of doubt we will exclude the participant from the study
- •No informed consent
- •History of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy)
- •History of skull opening or head trauma
- •Known or suspected non-adherence, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding
- •Intention to become pregnant during the course of the study
- •Body mass index (BMI) > 35
- •Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
结局指标
主要结局
Cross-sectional study: lumbosacral functional fMRI
时间窗: Baseline only
Activations in the gray matter of the lumbosacral cord, as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state). Spatiotemporal components of the BOLD signal as well as the couplings and anti-couplings between these components
Longitudinal study: brain functional MRI
时间窗: Change from baseline at 2-month, 6-month, and 12-month
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
Cross-sectional study: brain functional MRI
时间窗: Baseline only
Activations in the cortical and subcortical areas of the brain as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state)
Longitudinal study: lumbosacral functional fMRI
时间窗: Change from baseline at 2-month, 6-month, and 12-month
Activations in the gray matter of the lumbosacral cord, as a response to sensory, motor, and somatosensory stimulations, or no stimulation (resting state). Spatiotemporal components of the BOLD signal as well as the couplings and anti-couplings between these component
次要结局
- Cross-sectional study: structural MRI in spinal cord(Baseline only)
- Longitudinal study: diffusion MRI in the brain(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: magnetic resonance neurography of the lumbosacral plexus(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: magnetic resonance neurography of the lumbosacral plexus(Baseline only)
- Cross-sectional study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline only)
- Cross-sectional study: diffusion MRI in the spinal cord(Baseline only)
- Longitudinal study: structural MRI in spinal cord(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: structural MRI in the brain(Baseline only)
- Longitudinal study: structural MRI in the brain(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: nerve conduction study(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline only)
- Cross-sectional study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline only)
- Longitudinal study: diffusion MRI in the spinal cord(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: diffusion MRI in the brain(Baseline only)
- Cross-sectional study: nerve conduction study(Baseline only)
- Longitudinal study: motor evoked potentials (MEP)(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline only)
- Longitudinal study: Lower Extremities Motor Scale (LEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: Light touch (LT) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: sympathetic skin response including hand, sole and perineum recordings(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: Qualiveen questionnaire (only in patients with neurogenic lower urinary tract dysfunction)(Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation))
- Longitudinal study: Overactive Bladder (ICIQ-OAB) questionnaire (only in patients with neurogenic lower urinary tract dysfunction)(Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation))
- Cross-sectional study: motor evoked potentials (MEP)(Baseline only)
- Cross-sectional study: American Spinal Injury Association Impairment Scale (AIS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Baseline only)
- Cross-sectional study: European Multicenter Study about SCI (EMSCI) pain questionnaire(Baseline only)
- Longitudinal study: European Multicenter Study about SCI (EMSCI) pain questionnaire(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: Walking index for Spinal Cord Injury (WISCI)(Baseline only)
- Longitudinal study: Walking index for Spinal Cord Injury (WISCI)(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: Upper Extremities Motor Scale (UEMS) from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: sympathetic skin response including hand, sole and perineum recordings(Baseline only)
- Longitudinal study: Urinary Symptom Profile (USP) (only in patients with neurogenic lower urinary tract dysfunction)(Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation))
- Longitudinal study: Pin prick (PP) score from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol(Change from baseline at 2-month, 6-month, and 12-month)
- Cross-sectional study: Graded and Redefined Assessment of Strength, Sensation and Prehension (GRASSP)(Baseline only)
- Cross-sectional study: Spinal Cord Independence Measure (SCIM III)(Baseline only)
- Longitudinal study: Spinal Cord Independence Measure (SCIM III)(Change from baseline at 2-month, 6-month, and 12-month)
- Longitudinal study: International Prostate Symptom Score (IPSS) (only in patients with neurogenic lower urinary tract dysfunction)(Change between baseline and follow-up (6-12 weeks of tibial nerve stimulation))
研究者
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