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Summary

for people ages 15–50 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

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.

Keywords

Concussion Traumatic Brain Injury TBI MR mTBI NFL MRI Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Concussion

Eligibility

You can join if…

Open to people ages 15–50

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.

You CAN'T join if...

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
  9. Screening Axis I/II Disorders):
  10. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
  11. . Known cognitive dysfunction or structural brain disease/malformation;
  12. . Structural brain injury on prior neuroimaging findings;
  13. . Been prescribed antipsychotic/antiepileptic medications;
  14. . 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;
  15. . Contraindications to MRI scanning, including:
  16. Current or suspected pregnancy, per site practice;
  17. Other conditions that may constitute a hazard to the subject during study participation, per investigator;
  18. Inability to comply with any part of the site's MR safety policy.

Subjects will be excluded that have:- non-TBI (controls)

  1. Diagnosis of mTBI within the past 6 months;
  2. Prior (within past 10 years) moderate to severe TBI (GCS <13);
  3. Epilepsy with recurring seizures in past 10 years;
  4. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
  5. Alcohol abuse based on AUDIT-C screening;
  6. 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
  7. Screening Axis I/II Disorders):
  8. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
  9. Known cognitive dysfunction or structural brain disease/malformation;
  10. Structural brain injury on prior neuroimaging findings;
  11. . Been prescribed antipsychotic/antiepileptic medications;
  12. . 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;

Locations

  • University of California San Francisco accepting new patients
    San Francisco, California, 94121, United States
  • University of California-San Diego accepting new patients
    San Diego, California, 92161, United States
  • Houston Methodist Neurological Institute accepting new patients
    Houston, Texas, 77030, United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee, Wisconsin, 53226, United States
  • University of Pittsburgh Medical College accepting new patients
    Pittsburgh, Pennsylvania, 15203, United States
  • Universtiy of Miami Health System accepting new patients
    Miami, Florida, 33136, United States
  • Hospital for Special Surgery accepting new patients
    New York, New York, 10021, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GE Healthcare
ID
NCT02556177
Lead Scientist
Patrick Mukherjee
Study Type
Interventional
Last Updated
May 3, 2017
I’m interested in this study!