Transverse MyelitisISCoPE-TMNCT03336762
Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
An observational study of Transverse Myelitis, run by St George's, University of London at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transverse Myelitis
- What is being tested?
- Intra spinal pressure monitoring and Intra spinal microdialysis monitoring
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2017to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with formal diagnosis of transverse myelitis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's, University of London
London, SW17 0RE
About this study
ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis
Read the 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.
- Conditions
- Transverse Myelitis
- Being tested
- Intra spinal pressure monitoring, Intra spinal microdialysis monitoring
- Medical subject headings
- Myelitis, Transverse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra spinal pressure monitoringDiagnostic test
Sub dural pressure monitoring using a FDA approved intracranial pressure monitor
Intra spinal microdialysis monitoringDiagnostic test
Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to 1 year.
Secondary outcomes (2)
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
Measured: 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)
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start14 Feb 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse MyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Wings for Life, Neurosciences Research Foundation
- Responsible party
- Sponsor
- Investigators
- Marios Papadopoulos, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336762
- Sponsor's protocol ID
- 16.0089
- Acronym
- ISCoPE-TM
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
- ClinicalTrials.gov ID
- NCT03336762
- Acronym / sponsor ID
- ISCoPE-TM / 16.0089
- Conditions
- Transverse Myelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Wings for Life, Neurosciences Research Foundation
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with formal diagnosis of transverse myelitis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra spinal pressure monitoringSub dural pressure monitoring using a FDA approved intracranial pressure monitor | Diagnostic test | – |
| Intra spinal microdialysis monitoringSub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter | Diagnostic test | – |
Primary outcome
Number of patients with treatment related adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, up to 1 year.
To assess whether intraspinal pressure and metabolism monitoring in Transverse Myelitis patients is feasible and safe
2 secondary outcomes
Intra spinal pressure in mmHg
Time frame: Up to 7 days
Injury site metabolism measured using surface microdialysis.
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marios Papadopoulos, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transverse Myelitis, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related adverse events as assessed by CTCAE v4.0 (time frame: Through study completion, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.