Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis (ISCoPE-TM)

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

Study Overview

• Status: Completed
• Conditions: Transverse Myelitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • St George's, University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients with formal diagnosis of transverse myelitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with treatment related adverse events as assessed by CTCAE v4.0	To assess whether intraspinal pressure and metabolism monitoring in Transverse Myelitis patients is feasible and safe	Through study completion, up to 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra spinal pressure in mmHg	To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes raised intra spinal pressure, low spinal cord perfusion pressure	Up to 7 days
Injury site metabolism measured using surface microdialysis.	To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes deranged spinal cord metabolites (glucose, lactate, pyruvate, glycerol, glutamate)	Up to 7 days

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: Wings for Life; Neurosciences Research Foundation
• Investigators: Principal Investigator: Marios Papadopoulos, MD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Central Nervous System Infections; Neurodegenerative Diseases; Spinal Cord Diseases; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Myelitis; Myelitis, Transverse
• Other Study ID Numbers: 16.0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No