Clinical trial NCT03312608: Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation
Official title: Cerebral Reorganization in Cervical Myelopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Myelopathy
Keywords: cerebral reorganization, TMS
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Spine Society (Deutsche Wirbelsäulenstiftung)
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital of Cologne
name: University Hospital Munich
First posted: 2017-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * patients with symptomatic/asymptomatic cervical spondylotic myelopathy scheduled for surgery or conservative Treatment
* healthy subjects without any neurological disease

Brief summary: 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).

Detailed description: 120 patients with DCM due to cervical spinal canal stenosis will be examined preoperatively and postoperatively with nTMS. On the basis of the initial Japanese Orthopedic Association (JOA) Score two patient groups will be established (JOA≤12/\>12). The resting motor threshold, recruitment curve, cortical silent period and motor area will be determined. Accordingly, 40 healthy subjects will be examined.

To the investigators knowledge, this study is the first to analyze changes of corticospinal excitability and reorganization in patients with cervical spondylotic myelopathy with navigated TMS. In the present study, there was a significant difference in parameters of excitability and motor area activation between the severely symptomatic and clinically stable patient group. The investigators analysis showed that chronic CSM induces a recruitment of the non-primary motor area and corticospinal disinhibition, so that axonal damage can be compensated through recruitment of new cortical and supplementary motor connections, to a certain degree. Upon exhaustion of these mechanisms further axonal damage translates directly into new neurological deficits. These results lay the ground for a novel concept in CSM, the "corticospinal reserve capacity".

This study lays the foundation for future research to examine the pathomechanisms in CSM. Functional reorganization occurs on a spinal as well as on a cortical level. The concept of the corticospinal reseve capacity describes a compensatory, increased recruitment of non primary motor areas and corticospinal disinhibition in order to preserve motor function. By detecting the degree of reorganization, a stratification for an unfavourable as well as stable clinical course could be made. This innovative approach to describe the pathomechanisms in CSM might revise current concepts of clinical diagnostics and might have an impact on future treatment strategies.

Eligibility criteria: 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.

Primary outcomes:
measure: Corticospinal reserve capacity
timeFrame: preoperative
measure: Change in corticospinal reserve capacity
timeFrame: 9 months, 24 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of neurosurgery Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anna Zdunczyk, M.D.
role: PRINCIPAL_INVESTIGATOR
References: