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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04796987
Other study ID # KAEK/2020.07.129
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date April 22, 2021

Study information

Verified date May 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

Cervical myelopathy (CM) is a frequent degenerative disease of the cervical spine that occurs as a result of compression of the spinal cord. In evaluating of this disease and determining treatment options, the patient's clinic and radiological modalities should be evaluated together. The current imaging procedures for CM are plain roentgenograms, computed tomography and magnetic resonance imaging (MRI). However, MRI in CM is more valuable in evaluating of the disc, spinal cord and other soft tissues compared to other imaging methods. Artificial intelligence technologies also used in many health applications such as medical image analysis, biological signal analysis, etc. 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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date April 22, 2021
Est. primary completion date April 22, 2021
Accepts healthy volunteers
Gender All
Age group 32 Years to 77 Years
Eligibility Inclusion Criteria: - 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 - 30-80 years age. Exclusion Criteria: - Patients with a previous history of cervical spinal surgery and has a systematic disease (rheumatologic or neural disease) .

Study Design


Intervention

Diagnostic Test:
Convolutional Neural Network
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.

Locations

Country Name City State
Turkey Istanbul University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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