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Completed

NCT Number: NCT03920995

Multi-center Database Registry to Study Thalamus Changes Using AI in MS

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University at Buffalo

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Multi-center registry of MRI scans

    Time frame: 2 years

    Measuring the ability of DeepGRAI to measure thalamus volume as a predictor of clinical outcomes for patients with multiple sclerosis

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

  • Celgene

Registry information

Official study title

Creation of a Multi-center Database Registry to Study Real World Thalamus Volume Changes by Use of Artificial Intelligence in Patients With Multiple Sclerosis (MS)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2019
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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