Injured Spinal Cord Pressure Evaluation Study

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03336762
Study type	Observational
Source	St George's, University of London
Contact
Status	Completed
Phase
Start date	February 14, 2017
Completion date	August 1, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis — ISCoPE-TM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms