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Completed

NCT Number: NCT03336762

Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intra spinal pressure monitoring

Diagnostic Test

Sub dural pressure monitoring using a FDA approved intracranial pressure monitor

Intra spinal microdialysis monitoring

Diagnostic Test

Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter

Primary outcomes

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

    Time frame: Through study completion, up to 1 year.

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

Secondary outcomes

  1. Intra spinal pressure in mmHg

    Time frame: Up to 7 days

    To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes raised intra spinal pressure, low spinal cord perfusion pressure

  2. Injury site metabolism measured using surface microdialysis.

    Time frame: Up to 7 days

    To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes deranged spinal cord metabolites (glucose, lactate, pyruvate, glycerol, glutamate)

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • Neurosciences Research Foundation
  • Wings for Life

Registry information

Acronym: ISCoPE-TM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2017
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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