NCT04796987

Brief Summary

Deep learning technology has been used increasingly in spine surgery as well as in many medical fields. However, it is noticed that most of the studies about this subject in the literature have been conducted except of the cervical spine. In this study, we aimed to demonstrate the effectiveness of the deep learning algorithm in the diagnosis of cervical myelomalacia compared to conventional diagnostic methods. Artificial neural networks, a machine learning technique, have been used in several industrial and research fields increasingly. The development of computational units and the increasing amount of data led to the development of new methods on artificial neural networks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

7 days

First QC Date

March 11, 2021

Last Update Submit

May 27, 2021

Conditions

Keywords

neural networkdeep learningcervical myelopathy

Outcome Measures

Primary Outcomes (2)

  • The value of confusion matrix accuracy for sagittal views

    It is a specific table layout that allows visualization of the performance of an algorithm.

    1 day

  • The value of confusion matrix accuracy for axial views

    It is a specific table layout that allows visualization of the performance of an algorithm.

    1 day

Study Arms (2)

cervical myelopathy

MR images of patients with cervical myelopathy

Diagnostic Test: Convolutional Neural Network

normal

normal section of the MRI of patients with cervical myelopathy

Diagnostic Test: Convolutional Neural Network

Interventions

Convolutional neural networks, a machine learning technique, have been used in several industrial and research fields increasingly. The development of computational units and the increasing amount of data led to the development of new methods on artificial neural networks. Deep learning (DL) is a multi-layered neural network in which feature extraction is done automatically. It extends traditional neural networks by adding more hidden layers to the network architecture between the input and output layers to model more complex and nonlinear relationships.

cervical myelopathynormal

Eligibility Criteria

Age32 Years - 77 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants are aged 30-80 years, who have cervical myelomalacia that proved in MRI.

You may qualify if:

  • the patients with classical cervical myelomalacia sypmtoms such as neck pain and stiffness, weakness and clumsiness at the upper extremities or gait difficulties and radiological findings of spinal compression
  • years age.

You may not qualify if:

  • Patients with a previous history of cervical spinal surgery and has a systematic disease (rheumatologic or neural disease) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Convolutional Neural Networks

Intervention Hierarchy (Ancestors)

Neural Networks, ComputerMathematical Concepts

Study Officials

  • Hakan Yilmaz

    Karabuk University, Faculty of Engineering

    PRINCIPAL INVESTIGATOR
  • Murat Korkmaz

    Istanbul University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 15, 2021

Study Start

April 15, 2021

Primary Completion

April 22, 2021

Study Completion

April 22, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

It can be shared after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after publication

Locations