Clinical trial · Observational
Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis
NCT03336762CI-TRIAL-00049353ISCoPE-TMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transverse Myelitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra spinal microdialysis monitoring | Diagnostic Test | — | UNRESOLVED |
| Intra spinal pressure monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with treatment related adverse events as assessed by CTCAE v4.0
- timeFrame
- Through study completion, up to 1 year.
- description
- To assess whether intraspinal pressure and metabolism monitoring in Transverse Myelitis patients is feasible and safe
Secondary outcomes (2)
- measure
- Intra spinal pressure in mmHg
- timeFrame
- Up to 7 days
- description
- To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes raised intra spinal pressure, low spinal cord perfusion pressure
- measure
- Injury site metabolism measured using surface microdialysis.
- timeFrame
- Up to 7 days
- description
- To determine whether the swollen, enlarged spinal cord in patients with transverse myelitis causes deranged spinal cord metabolites (glucose, lactate, pyruvate, glycerol, glutamate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.