The COMP-CORD Study
Research type
Research Study
Full title
An observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: The COMP-CORD Study
IRAS ID
315335
Contact name
Mark R Kotter
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Degenerative cervical myelopathy (DCM) is a disabling spinal disorder characterized by sensorimotor deficits of upper and lower limbs, neurogenic bladder dysfunction and neuropathic pain. When suspected, cervical MRI helps to reveal spinal cord compression, and rule out alternative diagnoses. However, the correlation between radiological findings and symptoms is poor; spinal cord compression is commonly incidental, and MRI alone cannot determine when to offer surgery or predict the response to treatment.
Cerebrospinal fluid pressure (CSFP) analysis may complement MRI, by providing a quantitative appreciation of cord compression. Prior to MRI, a simplified version of CSFP was a common part of the diagnostic workup for spinal cord compression. The advent of real-time computerised monitoring means this can now be more much detailed. A group from Balgrist University Hospital, Zurich, Switzerland, therefore recently revisited CSFP in DCM, confirming the safety, feasibility, and early clinical value. They are now extending their study, incorporating additional sites across Europe, to externally validate these findings, but also begin to evaluate the clinical utility of findings. CSFP measurement is a routine of care at Cambridge University Hospital for other neurological conditions, including Normal Pressure Hydrocephalus and Idiopathic Intracranial Hypertension. Cambridge will therefore act as one site, and this protocol relates specifically to the study’s conduct at Cambridge. Analysis will be conducted at the central study site using pseudo-anonymised data. No personal identifiable information will leave Cambridge.
Twenty patients diagnosed with DCM undergoing surgical decompression will receive standardized lumbar CSFP-monitoring immediately before, during and 24-hrs after operation. CSFP measurements including opening pressure, CSF pulsation, at rest or during stimulation (i.e. Valsalva maneuver, Queckenstedt's test) will be recorded. Arterial blood pressure will be recorded peri- and postoperatively to calculate spinal cord perfusion pressure (SCPP) and spinal vascular reactivity index (sPRx). These measures will be compared to clinical and radiographic findings, including MR-imaging.
This interdisciplinary study will provide the first multicenter data on CSFP in DCM before, during and after surgical decompression.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0112
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion