Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 844 for:    cervical AND Brain

Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation (CReMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312608
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
German Spine Society (Deutsche Wirbelsäulenstiftung)
University Hospital Inselspital, Berne
University Hospital of Cologne
University Hospital Munich
Information provided by (Responsible Party):
Anna Zdunczyk, Charite University, Berlin, Germany

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).

Condition or disease Intervention/treatment
Degenerative Myelopathy Diagnostic Test: Navigated transcranial magnetic stimulation

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cerebral Reorganization in Cervical Myelopathy
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Corticospinal reserve capacity [ Time Frame: preoperative ]
    Comparison of corticospinal reserve capacity (defined by recruitment curve, cortical silent period, motor area) compared to healthy control group

  2. Change in corticospinal reserve capacity [ Time Frame: 9 months, 24 months postoperatively ]
    Postoperative change in corticospinal reserve capacity compared to clinical symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312608


Contacts
Layout table for location contacts
Contact: Anna Zdunczyk, M.D. 004930450660193 anna.zdunczyk@charite.de

Locations
Layout table for location information
Germany
Department of neurosurgery Charité Recruiting
Berlin, Germany, 10117
Contact: Anna Zdunczyk, M.D.    030/450660193    anna.zdunczyk@charite.de   
Principal Investigator: Peter Vajkoczy, M.D.         
Principal Investigator: Thomas Picht, M.D.         
Sub-Investigator: Sandro Krieg, M.D.         
Sub-Investigator: Carolin Weiss-Lucas, M.D.         
Sub-Investigator: Kathleen Seidel, M.D.         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Spine Society (Deutsche Wirbelsäulenstiftung)
University Hospital Inselspital, Berne
University Hospital of Cologne
University Hospital Munich
Investigators
Layout table for investigator information
Principal Investigator: Anna Zdunczyk, M.D. Charite University, Berlin, Germany

Layout table for additonal information
Responsible Party: Anna Zdunczyk, principal investigator, physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03312608     History of Changes
Other Study ID Numbers: 89830535
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study results, study protocol and study report will be shared with other Researchers during international congresses and peer reviewed publications
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: during the time of the study
Access Criteria: only as a congress presentation or publication presenting the results of the study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Zdunczyk, Charite University, Berlin, Germany:
cerebral reorganization, TMS
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases