Advanced MRI Applications for Mild Traumatic Brain Injury (TBI)

This study has been terminated.
(Sponsor terminated early as moving to a new larger study program)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT02070588
First received: February 18, 2014
Last updated: August 12, 2015
Last verified: August 2015
  Purpose

This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI).

These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.

Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").


Condition Intervention
Mild Traumatic Brain Injury
Traumatic Brain Injury
Device: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Advanced MRI Applications for Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • mTBI progression indicated by clinical neurological characteristics, MRI images, and quantitative MRI data from novel software [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).


Secondary Outcome Measures:
  • Subject demographics [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.

  • Operator set MRI parameters [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To record operator-adjusted parameters of the novel software on the MRI system


Enrollment: 112
Study Start Date: February 2014
Estimated Study Completion Date: September 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental: Diagnostic mTBI
MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
Device: MRI
MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Other Names:
  • Discovery MR750 & Discovery MR750w scanners
  • Investigation software
  • Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)
Placebo Comparator: Experimental: Diagnostic Non mTBI
MRI Diagnostic of Non injured subjects that are closely matched to mTBI
Device: MRI
MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
Other Names:
  • Discovery MR750 & Discovery MR750w scanners
  • Investigation software
  • Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)

Detailed Description:

This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 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 scanners using investigational or standard of care MR coils and a series of investigational MR Pulse Sequence sets (Application Packs). Each Application Pack will consist of a predetermined sequence of investigational pulse sequences (IPSs) optimized by GE Healthcare (GEHC) for mTBI. IPSs will be administered in a predetermined order as part of each Application Pack.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Segment 1: Inclusion Criteria for mTBI subjects

Subjects included in the main part of this study (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 in one of the first two intervals of the study, as follows:

    1. Meets criteria for enrollment in Encounter 1 (within 72 hours) OR
    2. Meets criteria for enrollment in Encounter 2 (within 8±2 days)
  3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.

Segment 1: Exclusion Criteria for mTBI subjects

Subjects will be excluded that have:

  1. Loss of consciousness (LOC) ≥15 minutes;
  2. Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
  3. Diagnosis of moderate to severe TBI or GCS <13;
  4. Structural brain injury indicated by previous neuroimaging findings;
  5. Previous history of moderate to severe TBI;
  6. Any previous history of mild TBI within the past 12 months;
  7. Previously diagnosed brain white matter disease;
  8. History of seizures within the past 10 years;
  9. History of self-reported illicit drug abuse (except marijuana) in past 10 years;
  10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  11. 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 D - Screening for Exclusion based on Axis I or II Disorders):
  12. History of brain mass
  13. History of neurosurgery
  14. History of stroke
  15. History of dementia
  16. Known cognitive dysfunction
  17. Known structural brain disease or malformation
  18. Current anti-psychotic or antiepileptic medication usage
  19. That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
  20. Contraindications to MRI scanning, including:

    1. Current or suspected pregnancy per site clinical practice;
    2. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
    3. Inability to comply with any part of the site's MR safety policy.

Inclusion Criteria for Non-TBI subjects (Segment 2)

All included subjects will:

  1. Aged ≥15 and ≤50 years old at the time of enrollment;
  2. Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:

    1. Age,
    2. Gender,
    3. Sociodemographic characteristics, and
    4. Handedness.
  3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.

Exclusion Criteria for Non-TBI subjects (Segment 2)

Subjects will be excluded that:

  1. Are currently pregnant based on subject self-report of pregnancy status;
  2. Are currently enrolled in another Segment of this study;
  3. Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
  4. Prior diagnosis of mild TBI within the past 12 months;
  5. Have structural brain injury indicated by previous neuroimaging findings;
  6. Previous history of moderate to severe TBI within the past 10 years;
  7. Previously diagnosed brain white matter disease;
  8. History of seizures within the past 10 years;
  9. History of illicit drug abuse (except marijuana) within the past 10 years
  10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  11. 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 D - Screening for Exclusion based on Axis I or II Disorders):
  12. History of brain mass;
  13. History of neurosurgery;
  14. History of stroke;
  15. History of dementia;
  16. Known cognitive dysfunction;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070588

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 08540
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02070588     History of Changes
Other Study ID Numbers: 114-2013-GES-0017
Study First Received: February 18, 2014
Last Updated: August 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
TBI
mTBI
MR
MRI
Pulse Sequences
NFL

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on August 27, 2015