Injured Spinal Cord Pressure Evaluation (ISCoPE)

December 1, 2020 updated by: St George's, University of London

Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury

About a thousand people a year in the United Kingdom survive a spinal cord injury but are left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is more than half a billion pounds. We propose that after spinal cord injury, cord pressure at the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of measuring and reducing cord pressure after spinal cord injury is unknown.

The injured spinal cord is compressed by bone malalignment and cord swelling. Current management involves realigning and fixing the bony fragments using metal screws, rods and plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised hypothermia reduces intra spinal pressure and improves metabolism.

We will develop a novel method to measure cord pressure and metabolism at the injury site after spinal cord injury and determine whether the cord pressure rises, for how long, and with what impact on spinal cord metabolism.

This is a pilot study to find out whether spinal cord pressure and metabolism can be measured after spinal cord injury and whether they are effected by treatment choices. We will examine if spinal cord perfusion pressure correlates with clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • Recruiting
        • St George's, University of London
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnosis of traumatic spinal cord injury American Spinal Injuries Association grade A-C spinal cord injury Presents within 72hrs of injury Capacity to consent for study

Exclusion Criteria:

Concurrent major co-morbidity likely to influence outcome Other major concurrent injury likely to influence outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laminectomy
Comparison of bone decompression versus no decompression for reducing intra spinal pressure
Procedure: Insertion of intra spinal sub dural pressure monitor
Other Names:
  • codman microsensor transducer. Ref. 626638
ACTIVE_COMPARATOR: Duraplasty
Expansion duraplasty versus no duraplasty for reducing intraspinal pressure
Procedure: Insertion of intra spinal sub dural pressure monitor
Other Names:
  • codman microsensor transducer. Ref. 626638
Procedure: Insertion of sub dural microdialysis probe
Other Names:
  • CMA61, CMA microdialysis AB. Ref.8010226
ACTIVE_COMPARATOR: Hypothermia
Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
Procedure: Insertion of intra spinal sub dural pressure monitor
Other Names:
  • codman microsensor transducer. Ref. 626638
Procedure: Insertion of sub dural microdialysis probe
Other Names:
  • CMA61, CMA microdialysis AB. Ref.8010226

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra spinal pressure
Time Frame: 0-7 days
Intra spinal pressure measured for up to 7 days using sub dural probe
0-7 days
Spinal metabolites
Time Frame: 0-7 days
Spinal cord metabolites measured using microdialysis probe
0-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Collaborators

Foundation Wings For Life
Neurosciences Research Foundation

Investigators

  • Principal Investigator: Marios C Papadopoulos, MD, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.0151
  • 10/H0807/23 (REGISTRY: Research ethics commitee - Camberwell St Giles)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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