NL-OMON51027已完成3 期
Clinical assessment of upper extremity performance in individuals with spinal cord injury using the LIFT System to deliver non-invasive electrical spinal stimulation (ARC Therapy) - The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Key Inclusion Criteria:
- •Subjects must meet all the following criteria:
- •1. At least 22 years old and no older than 75 years old at the time of
- •2. Non-progressive cervical spinal cord injury from C2-C8 inclusive
- •3. American Spinal Injury Association (ASIA) Impairment Scale (AIS)
- •classification B, C, or D
- •4. Indicated for upper extremity training procedures by subject's treating
- •physician or a physical therapist
- •5. Minimum 12 months post-injury
- •6. Capable of providing informed consent
排除标准
- •Key Exclusion Criteria:
- •Subjects must not meet any of the following criteria:
- •1. Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined
- •by the Investigator
- •2. Has any unstable or significant medical condition that is likely to
- •interfere with study procedures or likely to confound study endpoint
- •evaluations like severe neuropathic pain, depression, mood disorders or other
- •cognitive disorders
- •3. Has been diagnosed with autonomic dysreflexia that is severe, unstable, and
- •uncontrolled
- •4. Requires ventilator support
- •5. Has an autoimmune etiology of spinal cord dysfunction/injury
- •6. Spasms that limit the ability of the subjects to participate in the study
- •training as determined by the Investigator
- •7. Breakdown in skin area that will come into contact with electrodes
- •8. Has any active implanted medical device
- •9. Pregnant, planning to become pregnant or currently breastfeeding
- •10. Concurrent participation in another drug or device trial that may interfere
- •with this study
- •11. Presence of syringomyelia as confirmed by an MRI
- •12.Total baclofen dose >30 mg per day
- •13. In the opinion of the investigators, the study is not safe or appropriate
- •for the participant
研究者
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