Degenerative Myelopathy Clinical Trial
— CReMeOfficial title:
Cerebral Reorganization in Cervical Myelopathy
In degenerative cervical myelopathy (DCM) the dynamics of disease progression and the outcome after surgical decompression vary inter individually and do not necessarily correlate with radiological findings. By better characterization of the underlying pathophysiology this study aims to improve diagnostic power in DCM using Navigated transcranial magnetic stimulation (nTMS).
Status | Recruiting |
Enrollment | 160 |
Est. completion date | February 1, 2023 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients with symptomatic/asymptomatic cervical spondylotic myelopathy scheduled for surgery (anterior and/ or posterior decompression) or conservative treatment. The radiological inclusion criteria are cervical spinal stenosis (C3-C7) associated with or without intramedullary high signal intensity lesion on T2-weighted MRI due to disc protrusion or spondylosis. - healthy subjects without any neurological disease Exclusion Criteria: - Exclusion criteria are other pathologies in the vicinity of the corticospinal tract above the lesion site (i.e. tumor, infarction), neuroinflammatory disease, high grade paresis of the upper extremity (BMRC<3), the existence of a cardiac pacemaker, deep brain stimulation electrodes or pregnancy. |
Country | Name | City | State |
---|---|---|---|
Germany | Department of neurosurgery Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | German Spine Society, University Hospital Inselspital, Berne, University Hospital Munich, University Hospital of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corticospinal reserve capacity | Comparison of corticospinal reserve capacity (defined by recruitment curve, cortical silent period, motor area) compared to healthy control group | preoperative | |
Primary | Change in corticospinal reserve capacity | Postoperative change in corticospinal reserve capacity compared to clinical symptoms | 9 months, 24 months postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05296889 -
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
|