An observational study in Transverse Myelitis, sponsored by St George's, University of London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by St George's, University of London · Observational
ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis
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.
32 studies on the registry are indexed under Myelitis, Transverse; 10 are open to participants now.
This study's enrollment of 1 is below the median of 98 across 12 observational studies indexed under Myelitis, Transverse.
Browse Myelitis, Transverse studies →St George's, University of London is the lead sponsor of 106 studies on the registry; 12 are open to participants now.
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Inpatients with formal diagnosis of transverse myelitis
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sub dural pressure monitoring using a FDA approved intracranial pressure monitor
Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter
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
Time frame: Through study completion, up to 1 year.
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
Time frame: 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)
Time frame: Up to 7 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Aug 2020, 41 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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St George's, University of London →