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临床试验/NCT03336762
NCT03336762已完成不适用

Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

St George's, University of London1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
1
主要终点
Number of patients with treatment related adverse events as assessed by CTCAE v4.0

研究概览

简要总结

ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis

详细描述

Transverse myelitis (TM) is a rare inflammatory condition of the spinal cord. It is characterised by rapid onset of motor, sensory or autonomic dysfunction causing neurological deficit. It has a diverse range of causes; most commonly it is associated with multiple sclerosis and neuromyelitis optica also known as Devic's disease or Devic's syndrome, is a heterogeneous condition consisting of the simultaneous inflammation and demyelination of the optic nerve (optic neuritis) and the spinal cord (myelitis). It affects approximately 1900 adults and children in the UK annually, with 350 cases per year of unknown cause.

Outcome in TM is variable; e.g. neuromyelitis optica mortality can be 30% . There is a relationship between the severity of neurological symptoms at presentation and the eventual outcome. When a patient is ASIA (American spinal injuries association) A or tetraplegic at presentation, they are less likely to recover than when ASIA B/C or paraplegic. Approximately 30% of patients will be ASIA A-C after a TM episode.

There are several pathological mechanisms which could increase the risk of decreased blood supply and further neurological deficit in TM. The ISCoPE study has shown that in traumatic spinal cord injury when swelling causes mechanical compression of the cord against the dura there is increased intra spinal pressure (ISP).

The Investigators propose to monitor the ISP and spinal cord metabolites in 10 TM patients with MRI evidence of a swollen enlarged spinal cord. There has never been a study looking at ISP in TM patients before. The optimum blood pressure in patients with TM is not known.

The investigators aim to observe a previously unrecognised pathological mechanism of injury in TM. In the future this could lead on to novel treatments to improve drug delivery and neurological outcome in a condition otherwise associated with a poor outcome.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Transverse myelitis (as defined by TM working group 2002)
  • MRI evidence of swollen enlarged spinal cord. Defined as a larger cord diameter compared to the adjacent normal signal intensity spinal cord, with loss of cerebrospinal fluid space between cord and dura mater.
  • Age 18 - 70
  • Severe spinal cord injury (ASIA A - B)
  • Monitoring to start within 72 h of MRI
  • Capacity for informed consent

排除标准

  • Major co-morbidities likely to influence outcome
  • High anaesthetic risk precluding surgery
  • Multiple separate lesions on MRI spine
  • Lacking capacity or Unable to consent
  • Pregnancy

结局指标

主要结局

Number of patients with treatment related adverse events as assessed by CTCAE v4.0

时间窗: Through study completion, up to 1 year.

To assess whether intraspinal pressure and metabolism monitoring in Transverse Myelitis patients is feasible and safe

次要结局

  • Injury site metabolism measured using surface microdialysis.(Up to 7 days)
  • Intra spinal pressure in mmHg(Up to 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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