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临床试验/NL-OMON49181
NL-OMON49181撤回不适用

Study on feasibility of Targeted epidural spinal stimulation to Improve MObility recovery in patients with sub-acute spinal cord injury - STIMO-2

École Polytechnique Fédérale de Lausanne0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Patient enrolled in the EMSCI study
  • 2. Patient eligible following stratification based on URP model* (see Figure 3)
  • 3. Age 18 to 70 years old included
  • 4. Focal spinal cord injury due to trauma
  • 5. Patient with history of SCI within the past 6 months (sub-acute SCI)
  • 6. Level of lesion (confirmed by MRI):
  • o vertebral lesion T11 or above, and the distance between the tip of the conus
  • medullaris and the location of spinal cord damage must be at least 70 mm,
  • allowing for electrode placement
  • o and neurological lesion T11 or above, with conus function preserved
  • 7. Psychological condition compatible with study participation
  • 8. Able and willing to fulfil all study procedures

排除标准

  • 1. Spinal cord lesion due to neurodegenerative disease, spondylitis, tumor, or
  • presence of a spinal stenosis
  • 2. Severe or chronic medical disorder pre-existing SCI affecting rehabilitation
  • 3. Active implanted device such as a pacemaker, implantable cardiac
  • defibrillator or indication that might lead to implantation of such device.
  • 4. Inability to follow study procedures, e.g. due to language problems,
  • psychological disorders, dementia
  • 5. Hematological disorders with an increased risk of hemorrhagic event during
  • surgical interventions
  • 6. Permanent artificial ventilation
  • 7. Congenital or acquired lower limb abnormalities (affection of joints and
  • 8. Known or suspected drug or alcohol abuse
  • 9. Life expectancy of less than 12 months
  • 10. Pregnant or breast feeding
  • 11. Participation in other interventional study

研究者

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