Diffusion MRI-1 Imaging Database

Completed

• Conditions: Epilepsy; Healthy; Tumor; Other

• Registration Number: NCT03775694
• Lead Sponsor: Medtronic Spinal and Biologics

Brief Summary

The purpose of the dMRI-1 data collection study is to establish a database of clinical images and limited medical history information from patients that have previously received a dMRI scan. All data collected will be de-identified. No safety or effectiveness assessments will be completed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Study Start: 2019-06-06
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

1. Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s) with at least 30 unique gradient directions or < 18 years who has previously received an acceptable dMRI scan of any number of unique gradient directions and who is allowed to participate in this type of research project (e.g., IRB/EC approval with waiver of consent) per IRB/EC
2. Acceptable dMRI scan was completed prior to site activation in the study

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image assessment	Procedure

Trial Locations

Locations (6)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada