Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2)

• ClinicalTrials.gov Identifier: NCT02556177
• Recruitment Status: Completed
• First Posted: September 22, 2015
• Results First Posted: September 10, 2019
• Last Update Posted: September 10, 2019
• Sponsor: GE Healthcare
• Collaborator: ICON plc
• Information provided by (Responsible Party): GE Healthcare

Study Description

Brief Summary:

This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

Condition or disease	Intervention/treatment	Phase
Concussion; Traumatic Brain Injury	Procedure: MRI	Not Applicable

Detailed Description:

This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 477 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
• Study Start Date: November 2015
• Actual Primary Completion Date: January 31, 2018
• Actual Study Completion Date: January 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: mTBI patient group (Segment 1); 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)	Procedure: MRI; MRI scanning
Active Comparator: non-TBI patients (Segment 2); Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit	Procedure: MRI; MRI scanning

Outcome Measures

Primary Outcome Measures :

1. MRI Image Data Sets [ Time Frame: Per patient scanning over 3 months ]
   MRI image data sets collected from subjects who completed the study.
2. Neuropsychological Assessments [ Time Frame: Per patient scanning over 3 months ]
   Neuropsychological assessments collected from subjects who completed the study.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Subjects included as mTBI patients (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 within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.

Subjects included as non-mTBI controls (Segment 2) will:

1. Be aged ≥15 and ≤50 years old at the time of enrollment;
2. Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)
3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.

Exclusion Criteria:

Subjects will be excluded that have: mTBI

1. Loss of consciousness (LOC) ≥5 minutes;
2. Posttraumatic amnesia lasting ≥24 hr following mTBI;
3. Current or prior (within past 10 years) moderate to severe TBI
4. Diagnosis of mTBI within the past 6 months;
5. Epilepsy with recurring seizures in past 10 years;
6. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
7. Alcohol abuse based on AUDIT-C screening;
8. 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 C - Screening Axis I/II Disorders):
9. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
10. Known cognitive dysfunction or structural brain disease/malformation;
11. Structural brain injury on prior neuroimaging findings;
12. Been prescribed antipsychotic/antiepileptic medications;
13. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

14. Contraindications to MRI scanning, including:

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

Subjects will be excluded that have:- non-TBI (controls)

1. Diagnosis of mTBI within the past 6 months;
2. Prior (within past 10 years) moderate to severe TBI (GCS <13);
3. Epilepsy with recurring seizures in past 10 years;
4. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
5. Alcohol abuse based on AUDIT-C screening;
6. 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 C - Screening Axis I/II Disorders):
7. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
8. Known cognitive dysfunction or structural brain disease/malformation;
9. Structural brain injury on prior neuroimaging findings;
10. Been prescribed antipsychotic/antiepileptic medications;
11. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

Contacts and Locations

Locations

United States, California

University of California-San Diego

San Diego, California, United States, 92161

University of California San Francisco

San Francisco, California, United States, 94121

United States, Florida

Universtiy of Miami Health System

Miami, Florida, United States, 33136

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

United States, Pennsylvania

University of Pittsburgh Medical College

Pittsburgh, Pennsylvania, United States, 15203

United States, Texas

Houston Methodist Neurological Institute

Houston, Texas, United States, 77030

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

GE Healthcare

ICON plc

Investigators

• Study Director: Victor Miranda, MD; GE Healthcare

  Study Documents (Full-Text)

Documents provided by GE Healthcare:

Study Protocol and Statistical Analysis Plan  [PDF] November 14, 2016

More Information

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT02556177
• Other Study ID Numbers: 114-2015-GES-0017
• First Posted: September 22, 2015
• Results First Posted: September 10, 2019
• Last Update Posted: September 10, 2019
• Last Verified: September 2019

Keywords provided by GE Healthcare:

TBI; MR; mTBI; NFL; MRI

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating