Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation

Degenerative Myelopathy Clinical Trial

— CReMe  

Official title:

Cerebral Reorganization in Cervical Myelopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312608
• Other study ID #: 89830535
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2017
• Last updated: October 12, 2017
• Start date: January 1, 2017
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2017
• Source: Charite University, Berlin, Germany
• Contact: Anna Zdunczyk, M.D.
• Phone: 004930450660193
• Email: anna.zdunczyk[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Degenerative Myelopathy
• Spinal Cord Diseases

Intervention

Diagnostic Test:
• Navigated transcranial magnetic stimulation

Locations

Country	Name	City	State
Germany	Department of neurosurgery Charité	Berlin

Sponsors (5)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Spine Society, University Hospital Inselspital, Berne, University Hospital Munich, University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

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