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
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
相似试验
招募中
不适用
Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit ImprovementSpinal Cord InjuriesNCT06455137Buddhist Tzu Chi General Hospital20
进行中(未招募)
不适用
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)Spinal Cord Injury at T1-T12 LevelTraumatic Thoracic Spinal Cord ContusionThoracic Spinal Cord TraumaTraumatic Thoracic Spinal Cord LacerationNCT04894734Nandan Lad, M.D., Ph.D.25
已完成
不适用
Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate PainSpinal Cord InjuryNCT05433064Buddhist Tzu Chi General Hospital12
终止
不适用
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) StudyFailed Back Surgery SyndromePost-Laminectomy SyndromeLow Back PainNCT01990287Abbott Medical Devices38
招募中
不适用
Targeting Cervical Epidural Spinal Cord Stimulation for Functional RecoveryTetraplegia/TetraparesisCervical MyelopathyCervical Spinal Cord InjuryNCT06701422Columbia University36
