Multiple Sclerosis Clinical Trial
Multi-center Database Registry to Study Thalamus Changes Using AI in MS
Summary
In this study the Investigator's propose to validate a newly developed approach, DeepGRAI (Deep Gray Rating via Artificial Intelligence), to simplify the calculation of thalamic atrophy in a clinical routine and allow academic and community neurologists to plan, perform, and publish novel and influential clinical research using data from clinical routine, by employing deep machine learning (DML) pattern recognition (PR) information through use of artificial intelligence (AI).
Full Description
This is a multicenter, observational, retrospective, cross-sectional and longitudinal population study of brain volume changes in MS patients. The retrospective electronic medical record (EMR) and brain MRI image data will be collected at participating MS centers and de-identified data will be integrated into a central research database. All the data to be integrated into the database has already been collected by physicians at the centers as part of their routine clinical practice and is thus non-interventional and retrospective in nature. This new approach will be compared to existing approaches of brain volume measurement that are currently widely available. This breakthrough approach would lead to potentially abandoning classis measurement of the specific brain volume structures and would be applicable in real-time in clinical routine.
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with relapsing-remitting (RR) MS
Access to raw MRI index scan images that meet all of the below criteria
MRI scan image acquired at index
The scan was performed on 1.5T or 3T scanners
The scan must have a T2-FLAIR sequence
Access to raw MRI post-index scan images that meet all of the below listed criteria
MRI scan image acquired at post-index
The scan was performed on 1.5T or 3T scanners
The scan must have a T2-FLAIR sequence
Age 18-85 at index
Fulfilling the MRI scan and clinical data requirements outlined in Table 2
None of the exclusion criteria
Exclusion Criteria:
Have received an investigational drug or experimental procedure during the study period
Women who were pregnant, or lactating at index or during the post-index period
Patients who had a relapse 30 days prior to the selected MRI scan date
Patients who received steroid treatment 30 days prior to the selected MRI scan date
Presence of other neurologic diseases affecting CNS
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There is 1 Location for this study
Buffalo New York, 14203, United States
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