TBI MR Study 3 Houston Methodist

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: MRI Diagnostic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Diagnostic mTBI<br>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) | Device: MRI Diagnostic<br>* 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<br>* Other names: Magnetic Resonance Image;|
| Placebo Comparator: Experimental: Diagnostic Non mTBI<br>MRI Diagnostic of Non injured subjects that are closely matched to mTBI | Device: MRI Diagnostic<br>* 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<br>* Other names: Magnetic Resonance Image;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Traumatic Brain Injury