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

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)

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with Multiple sclerosis who have 2 MRI scans

Description

Inclusion Criteria:

1. Patient diagnosed with relapsing-remitting (RR) MS

2. Access to raw MRI index scan images that meet all of the below criteria

   1. MRI scan image acquired at index
   2. The scan was performed on 1.5T or 3T scanners
   3. The scan must have a T2-FLAIR sequence

3. Access to raw MRI post-index scan images that meet all of the below listed criteria

   1. MRI scan image acquired at post-index
   2. The scan was performed on 1.5T or 3T scanners
   3. The scan must have a T2-FLAIR sequence
4. Age 18-85 at index
5. Fulfilling the MRI scan and clinical data requirements outlined in Table 2
6. None of the exclusion criteria

Exclusion Criteria:

1. Have received an investigational drug or experimental procedure during the study period
2. Women who were pregnant, or lactating at index or during the post-index period
3. Patients who had a relapse 30 days prior to the selected MRI scan date
4. Patients who received steroid treatment 30 days prior to the selected MRI scan date
5. Presence of other neurologic diseases affecting CNS

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-center registry of MRI scans	Measuring the ability of DeepGRAI to measure thalamus volume as a predictor of clinical outcomes for patients with multiple sclerosis	2 years

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: Celgene
• Investigators: Principal Investigator: Robert Zivadinov, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: N/A-NI-MS-PI-13632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No