Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation

NCT03312608 | Unknown

• 1 other identifier: 89830535
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Degenerative Myelopathy

Keywords

cerebral reorganization, TMS

Outcome Measures

Primary Outcomes (2)

• Corticospinal reserve capacity

  Comparison of corticospinal reserve capacity (defined by recruitment curve, cortical silent period, motor area) compared to healthy control group

  preoperative

• Change in corticospinal reserve capacity

  Postoperative change in corticospinal reserve capacity compared to clinical symptoms

  9 months, 24 months postoperatively

Study Arms (3)

mild myelopathy (JOA>12)

40 patients (JOA\>12) suffering from symptomatic or asymptomatic degenerative cervical myelopathy scheduled for surgery or conservative treatment. The radiological inclusion criteria are cervical spinal stenosis associated with or without intramedullary high signal intensity lesion on T2-weighted MRI. 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. By means of navigated transcranial magnetic stimulation the resting motor threshold, recruitment curve, cortical silent period and motor area will be determined.

Diagnostic Test: Navigated transcranial magnetic stimulation

moderate myelopathy

40 patients (JOA≤12) suffering from symptomatic degenerative cervical myelopathy scheduled for surgery (anterior and/ or posterior decompression) or conservative treatment. The radiological inclusion criteria are cervical spinal stenosis associated with or without intramedullary high signal intensity lesion on T2-weighted MRI. 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. By means of navigated transcranial magnetic stimulation the resting motor threshold, recruitment curve, cortical silent period and motor area will be determined.

Diagnostic Test: Navigated transcranial magnetic stimulation

healthy control

As a control group, 40 subjects will be included into the study. Exclusion criteria and examination protocol are identical with the patient group. By means of navigated transcranial magnetic stimulation the resting motor threshold, recruitment curve, cortical silent period and motor area will be determined.

Diagnostic Test: Navigated transcranial magnetic stimulation

Interventions

Navigated transcranial magnetic stimulation DIAGNOSTIC_TEST

healthy control; mild myelopathy (JOA>12); moderate myelopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• healthy subjects without any neurological disease

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Spine Society (Deutsche Wirbelsäulenstiftung): collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital of Cologne: collaborator
• University Hospital Munich: collaborator

Study Sites (1)

Department of neurosurgery Charité

Berlin, 10117, Germany

RECRUITING

Study Officials

• Anna Zdunczyk, M.D.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Zdunczyk, M.D.

CONTACT

004930450660193; anna.zdunczyk@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, physician

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 18, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2023
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: during the time of the study
• Access Criteria: only as a congress presentation or publication presenting the results of the study

Locations

DE (1)