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Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 | Clinical Trials | Clareo Health

COMPLETEDNA

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

NCT02556177•GE Healthcare

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.

Eligibility

Age

15 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects included as mTBI patients (Segment 1) will:
•1. Be aged ≥15 and ≤50 years old at the time of enrollment;
•2. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
•3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.
•Subjects included as non-mTBI controls (Segment 2) will:
•1. Be aged ≥15 and ≤50 years old at the time of enrollment;
•2. Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)
•3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.

Exclusion Criteria

•Subjects will be excluded that have: mTBI
•1. Loss of consciousness (LOC) ≥5 minutes;
•2. Posttraumatic amnesia lasting ≥24 hr following mTBI;
•3. Current or prior (within past 10 years) moderate to severe TBI
•4. Diagnosis of mTBI within the past 6 months;
•5. Epilepsy with recurring seizures in past 10 years;
•6. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
•7. Alcohol abuse based on AUDIT-C screening;
•8. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders):
•9. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
+20 more criteria

Locations (7)

University of California-San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Universtiy of Miami Health System

Miami, Florida, United States

Hospital for Special Surgery

New York, New York, United States

University of Pittsburgh Medical College

Pittsburgh, Pennsylvania, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

January 31, 2018

Completion Date

January 31, 2018

Last Updated

September 10, 2019

Enrollment

477

ACTUAL participants

Conditions

ConcussionTraumatic Brain Injury

Interventions

MRI

PROCEDURE

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

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Traumatic Brain Injury

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RECRUITING

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

NCT07455136

Traumatic Brain Injury

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RECRUITING

Hemodynamic ABI Monitor

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Carbon Dioxide Administration and Brain Waste Clearance

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury