Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

Completed · Not applicable

Conditions studied: Concussion, Traumatic Brain Injury

In brief

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.

Key facts

Study ID: NCT02556177
Run by: GE Healthcare
People needed: 477
Starts: 2015-11-01
Expected to finish: 2018-01-31
Last updated by the study team: 2019-09-10

Who can join

Age: 15 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subjects included as mTBI patients (Segment 1) will:
Be aged ≥15 and ≤50 years old at the time of enrollment;
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.
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:
Be aged ≥15 and ≤50 years old at the time of enrollment;
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)
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.

You may not qualify if…

Subjects will be excluded that have: mTBI
Loss of consciousness (LOC) ≥5 minutes;
Posttraumatic amnesia lasting ≥24 hr following mTBI;
Current or prior (within past 10 years) moderate to severe TBI
Diagnosis of mTBI within the past 6 months;
Epilepsy with recurring seizures in past 10 years;
Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
Alcohol abuse based on AUDIT-C screening;
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):
History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
Known cognitive dysfunction or structural brain disease/malformation;
Structural brain injury on prior neuroimaging findings;
Been prescribed antipsychotic/antiepileptic medications;
Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
Contraindications to MRI scanning, including:
Current or suspected pregnancy, per site practice;
Other conditions that may constitute a hazard to the subject during study participation, per investigator;
Inability to comply with any part of the site's MR safety policy.
Subjects will be excluded that have:- non-TBI (controls)
Diagnosis of mTBI within the past 6 months;
Prior (within past 10 years) moderate to severe TBI (GCS <13);
Epilepsy with recurring seizures in past 10 years;
Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
Alcohol abuse based on AUDIT-C screening;
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):

Where it is running

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

Full record on ClinicalTrials.gov

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