Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF (TBI-2)

This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: MRI Diagnostic

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • University of California at San Francisco (UCSF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. 6.6. 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..

6.6.2. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Diagnostic mTBI; MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)	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 Names: Magnetic Resonance Image
Placebo Comparator: Experimental: Diagnostic Non mTBI; MRI Diagnostic of Non injured subjects that are closely matched to mTBI	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 Names: Magnetic Resonance Image

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Patrik Mukherjee, MD. PhD, University of California at San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 19, 2014

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Mild Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 114-2014-GES-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO