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TBI MR Study 3 Houston Methodist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218216
Recruitment Status : Terminated (Sponsor terminated study early to start a larger feasability study)
First Posted : August 18, 2014
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE August 18, 2014
Results First Submitted Date  ICMJE April 27, 2017
Results First Posted Date  ICMJE July 24, 2017
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software [ Time Frame: Baseline to 3 months ]
To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TBI MR Study 3 Houston Methodist
Official Title  ICMJE Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
Brief 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

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 Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE 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
Other Name: Magnetic Resonance Image
Study Arms  ICMJE
  • Experimental: Experimental: Diagnostic mTBI
    MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
    Intervention: Device: MRI Diagnostic
  • Placebo Comparator: Experimental: Diagnostic Non mTBI
    MRI Diagnostic of Non injured subjects that are closely matched to mTBI
    Intervention: Device: MRI Diagnostic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2015)
16
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2014)
500
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Segment 1 (mTBI patient) Inclusion and Exclusion Criteria 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 F - 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.

Segment 2 (non-TBI subject) Inclusion and Exclusion Criteria 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 F - 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. Have 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218216
Other Study ID Numbers  ICMJE 114-2014-GES-0046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph C Masdeu, MD. PhD Houston Methodist Neurological Institute
PRS Account GE Healthcare
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP