NCT04952831

Brief Summary

diffusion MRI in evaluates and predicts prognosis in CSM

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 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

September 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 7, 2021

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

June 28, 2021

Last Update Submit

June 28, 2021

Conditions

Cervical Spondylotic Myelopathy

Outcome Measures

Primary Outcomes (2)

  • Postoperative neurologic improvement

    Postoperative modified Japanese Orthopaedic Association (mJOA) and recovery rate (RR) at 3-month, 6-month, 12-month, and 24-month for patients

    3-month, 6-month, 12-month, and 24-month

  • diagnosis of CSM

    whether participants are diagnosed as CSM at baseline.

    at baseline

Study Arms (4)

Patients with mild CSM

mJOA score ≥15

Other: diffusion MRI (dMRI)

Patients with moderate CSM

mJOA score 13\~14

Other: diffusion MRI (dMRI)

Patients with severe CSM

mJOA score ≤ 12

Other: diffusion MRI (dMRI)

Controls

health volunteers

Other: diffusion MRI (dMRI)

Interventions

diffusion MRI (dMRI)OTHER

All participants underwent dMRI scan at baseline

ControlsPatients with mild CSMPatients with moderate CSMPatients with severe CSM

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients come from the Peking University Third Hospital. Healthy volunteers come from online recruitment.

You may qualify if:

  • ages ranged 30-75
  • compliance to MRI scan
  • no MRI contraindication
  • (Patients) clinical diagnosis of CSM and surgery in our hospital
  • (Healthy controls) no spinal cord dysfunction

You may not qualify if:

  • prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, spinal cord injury, motor neuron disease, or spinal cord tumour
  • images with motion artifact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Interventions

Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Huishu Yuan, Dr

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 7, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2024

Last Updated

July 7, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)