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TBI MR Study 3 Houston Methodist

NCT02218216 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-24

Study results available
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Summary

This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.

The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.

Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor

Conditions

Interventions

DEVICE

MRI Diagnostic

Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Joseph C Masdeu, MD. PhD · Houston Methodist Neurological Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-05-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218216 on ClinicalTrials.gov