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

Sponsor
St George's, University of London (Other)
Overall Status
Completed
CT.gov ID
NCT03336762
Collaborator
Wings for Life (Other), Neurosciences Research Foundation (Other)
1
Enrollment
1
Location
41.5
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Intra spinal pressure monitoring
  • Diagnostic Test: Intra spinal microdialysis monitoring

Detailed 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

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
Actual Study Start Date :
Feb 14, 2017
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Number of patients with treatment related adverse events as assessed by CTCAE v4.0 [Through study completion, up to 1 year.]

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

Secondary Outcome Measures

  1. Intra spinal pressure in mmHg [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. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St George's, University of London London United Kingdom SW17 0RE

Sponsors and Collaborators

  • St George's, University of London
  • Wings for Life
  • Neurosciences Research Foundation

Investigators

  • Principal Investigator: Marios Papadopoulos, MD, St George's, University of London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT03336762
Other Study ID Numbers:
  • 16.0089
First Posted:
Nov 8, 2017
Last Update Posted:
Jan 11, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myelitis
Myelitis, Transverse

Study Results

No Results Posted as of Jan 11, 2021