NCT06094166

Brief Summary

Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3.7 years

First QC Date

September 12, 2023

Last Update Submit

October 16, 2023

Conditions

Degenerative Cervical Spinal MyelopathyCervical Spinal Cord Compression

Outcome Measures

Primary Outcomes (5)

  • Anatomical MRI metrics

    compressive ratio (CR)

    45 minutes

  • Anatomical MRI metrics

    cross-sectional area (CSA)

    45 minutes

  • dMRI: signs of microstructural myelopathy

    fractional anisotropy

    45 minutes

  • MRS: signs of metabolic myelopathy (above the level of compression)

    Myo-ins/NAA ratio

    45 minutes

  • Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)

    remote cervical cord atrophy

    45 minutes

Secondary Outcomes (1)

  • IVIM and T2*WM/GM signal-intensity ratio

    45 minutes

Study Arms (2)

NMDCC

non-myelopathic cervical spinal cord compression

Diagnostic Test: MRI

healthy controls

subjects with no MR signs of cervical spinal cord compression

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

Quantitative imaging MR parameters

NMDCChealthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy controls and patients with non-myelopathic cervical spinal cord compression (NMDC)

You may qualify if:

  • Subject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.

You may not qualify if:

  • A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
  • Pregnancy
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Masaryk University, Brno

Brno, Czechia

RECRUITING

Study Officials

  • Josef Bednarik, Prof. MD.

    Masaryk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Horak, MD. PhD.

CONTACT

+420724273734horak.tomas@fnbrno.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. MUDr. Josef Bednarik, CSc., FCMA, FEAN

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 23, 2023

Study Start

May 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

CZ(1)