Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

NCT03336762 | Completed DMC

• 1 other identifier: 16.0089
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Transverse Myelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intra spinal pressure in mmHg

  Up to 7 days

• Injury site metabolism measured using surface microdialysis.

  Up to 7 days

Interventions

Intra spinal pressure monitoring DIAGNOSTIC_TEST

Sub dural pressure monitoring using a FDA approved intracranial pressure monitor

Intra spinal microdialysis monitoring DIAGNOSTIC_TEST

Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients with formal diagnosis of transverse myelitis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• Wings for Life: collaborator
• Neurosciences Research Foundation: collaborator

Study Sites (1)

St George's, University of London

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Myelitis, Transverse

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Demyelinating Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marios Papadopoulos, MD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 8, 2017
• Study Start: February 14, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)