Injured Spinal Cord Pressure Evaluation Study – Transverse Myelitis

Brief Title

Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

Official Title

Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

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
    

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 Type

Observational


Primary Outcome

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

Secondary Outcome

 Intra spinal pressure in mmHg

Condition

Transverse Myelitis

Intervention

Intra spinal pressure monitoring


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

1

Start Date

February 14, 2017

Completion Date

August 1, 2020

Primary Completion Date

August 1, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Marios Papadopoulos, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03336762

Organization ID

16.0089


Responsible Party

Sponsor

Study Sponsor

St George's, University of London

Collaborators

 Wings for Life

Study Sponsor

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


Verification Date

January 2021