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TBI MR Study 3 Houston Methodist

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI Diagnostic
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Brain Injury focused on measuring Mild Traumatic Brain Injury

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Houston Methodist Neurological Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Diagnostic mTBI

Experimental: Diagnostic Non mTBI

Arm Description

MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)

MRI Diagnostic of Non injured subjects that are closely matched to mTBI

Outcomes

Primary Outcome Measures

mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2014
Last Updated
June 22, 2017
Sponsor
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02218216
Brief Title
TBI MR Study 3 Houston Methodist
Official Title
Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study early to start a larger feasability study
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Diagnostic mTBI
Arm Type
Experimental
Arm Description
MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
Arm Title
Experimental: Diagnostic Non mTBI
Arm Type
Placebo Comparator
Arm Description
MRI Diagnostic of Non injured subjects that are closely matched to mTBI
Intervention Type
Device
Intervention Name(s)
MRI Diagnostic
Other Intervention Name(s)
Magnetic Resonance Image
Intervention Description
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
Primary Outcome Measure Information:
Title
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
Description
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
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 in one of the first two intervals of the study, as follows: Meets criteria for enrollment in Encounter 1 (within 72 hours), or Meets criteria for enrollment in Encounter 2 (within 8±2 days) 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: Loss of consciousness (LOC) ≥15 minutes; Posttraumatic amnesia lasting ≥24 hr following a recent TBI event; Diagnosis of moderate to severe TBI or GCS <13; Structural brain injury indicated by previous neuroimaging findings; Previous history of moderate to severe TBI; Any previous history of mild TBI within the past 12 months; Previously diagnosed brain white matter disease; History of seizures within the past 10 years; History of self-reported illicit drug abuse (except marijuana) in past 10 years; History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria); 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): History of brain mass; History of neurosurgery; History of stroke; History of dementia; Known cognitive dysfunction; Known structural brain disease or malformation; Current anti-psychotic or antiepileptic medication usage; 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; Contraindications to MRI scanning, including: Current or suspected pregnancy per site clinical practice; Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator; 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: Aged ≥15 and ≤50 years old at the time of enrollment; Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to: Age, Gender, Sociodemographic characteristics, and Handedness. 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: Are currently pregnant based on subject self-report of pregnancy status; Are currently enrolled in another Segment of this study; Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator; Prior diagnosis of mild TBI within the past 12 months; Have structural brain injury indicated by previous neuroimaging findings; Previous history of moderate to severe TBI within the past 10 years; Previously diagnosed brain white matter disease; History of seizures within the past 10 years; History of illicit drug abuse (except marijuana) within the past 10 years History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria); 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): History of brain mass; History of neurosurgery; History of stroke; History of dementia; Known cognitive dysfunction; Known structural brain disease or malformation; Current anti-psychotic or antiepileptic medication usage; Have contraindications to MRI scanning, including: Current or suspected pregnancy per site clinical practice; Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator; Inability to comply with any part of the site's MR safety policy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph C Masdeu, MD. PhD
Organizational Affiliation
Houston Methodist Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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