Cervical Spondylotic Myelopathy
Conditions
Keywords
Cervical Spondylotic Myelopathy, spine, Biomarkers
Brief summary
Investigators believe that patients with cervical spondylotic myelopathy (CSM) have measurable changes in certain molecules in their blood compared with people without CSM. Investigators expect that these changes may be related to how severe a patient's condition is based on imaging and clinical exams. Investigators will also study how these molecules change before and after surgery to see whether they are related to how well patients recover. By combining these blood markers with clinical and imaging information, investigators hope to develop a tool that may help predict patient outcomes.
Detailed description
Cervical spondylotic myelopathy (CSM) represents the most common cause of non-traumatic spinal cord injury in adults (New et al., 2014) with an estimated prevalence of 605 per million in North America (Nouri et al., 2015). This degenerative condition leads to spinal cord compression which can result in severely debilitating symptoms such as weakness, loss of fine motor control, bowel and bladder dysfunction, and pain. Surgical decompression is often needed in patients with symptomatic neural element stenosis, and surgical decision-making is primarily based on clinical examination findings and imaging evidence of cervical spinal cord compression. However, the degree of spinal cord compression observed on imaging poorly correlates with the severity of neurologic dysfunction in cervical myelopathy patients (Nagata et al., 2012; Rhee et al., 2009). Additionally, there are no reliable objective measures or prognostic factors to aid in assessing patients best-suited for surgical decompression and recovery following surgery. This study aims to identify serum biomarkers of CSM injury severity and long-term outcomes. This proposal focuses on transcriptomic changes as well as radiographic and clinical data variables in CSM patients to characterize RNA biomarkers of injury and recovery, which has been studied to date. Identification of prognostic biomarkers of CSM may uncover new mechanisms underlying spinal cord injury and develop predictive algorithms for CSM treatment planning and prediction of long-term outcomes.
Interventions
None listed
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Inclusion Criteria: * Age \>18 * No neck pain * No radiculopathy or myelopathy symptoms * No trauma in the past 6 months * Does not meet
Exclusion criteria
. CSM Inclusion Criteria: * Age \>18 * Diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament. Healthy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of serum RNA biomarkers for CSM | Preoperative/baseline visit | Area under the receiver operating characteristic curve (AUC) comparing serum RNA biomarker levels in patients with CSM versus healthy controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between serum RNA biomarkers and radiographic CSM severity | Preoperative/baseline visit | — |
| Association between serum RNA biomarkers and clinical CSM severity | Preoperative visit through 2 years postoperatively | CSM severity measured by clinical and sensorimotor examinations |
| Association between serum RNA biomarkers and functional outcomes/recovery | Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively | Association between changes in candidate serum RNA biomarker levels and postoperative functional outcomes, including study questionnaires and sensorimotor examinations |
Countries
United States
Contacts
CONTACTDanielle Nieto, BA
CONTACTCatherine Ravikumar, MS
PRINCIPAL_INVESTIGATORNima Alan, MD
University of California San Francisco, Department of Neurological Surgery
Outcome results
None listed