NCT02556177

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

Detailed description

This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.

Conditions

• Concussion
• Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	MRI	MRI scanning

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2015-09-22
• Last updated: 2019-09-10
• Results posted: 2019-09-10

Locations

7 sites across 1 country: United States