Clinical trial NCT03336762: Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
Official title: Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transverse Myelitis
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Wings for Life
name: Neurosciences Research Foundation
First posted: 2017-11-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with formal diagnosis of 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.

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

Primary outcomes:
measure: Number of patients with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: Through study completion, up to 1 year.
Secondary outcomes:
measure: Intra spinal pressure in mmHg
timeFrame: Up to 7 days
measure: Injury site metabolism measured using surface microdialysis.
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
affiliation: St George's, University of London
name: Marios Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: