NCT02556177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

August 7, 2015

Results QC Date

September 4, 2018

Last Update Submit

September 9, 2019

Conditions

ConcussionTraumatic Brain Injury

Keywords

TBIMRmTBINFLMRI

Outcome Measures

Primary Outcomes (2)

  • MRI Image Data Sets

    MRI image data sets collected from subjects who completed the study.

    Per patient scanning over 3 months

  • Neuropsychological Assessments

    Neuropsychological assessments collected from subjects who completed the study.

    Per patient scanning over 3 months

Study Arms (2)

mTBI patient group (Segment 1)

ACTIVE COMPARATOR

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

non-TBI patients (Segment 2)

ACTIVE COMPARATOR

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

Interventions

MRIPROCEDURE

MRI scanning

mTBI patient group (Segment 1)non-TBI patients (Segment 2)

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects included as mTBI patients (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 within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
  • 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:
  • Be aged ≥15 and ≤50 years old at the time of enrollment;
  • 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)
  • 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.

You may not qualify if:

  • Subjects will be excluded that have: mTBI
  • Loss of consciousness (LOC) ≥5 minutes;
  • Posttraumatic amnesia lasting ≥24 hr following mTBI;
  • Current or prior (within past 10 years) moderate to severe TBI
  • Diagnosis of mTBI within the past 6 months;
  • Epilepsy with recurring seizures in past 10 years;
  • Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
  • Alcohol abuse based on AUDIT-C screening;
  • 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):
  • History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
  • Known cognitive dysfunction or structural brain disease/malformation;
  • Structural brain injury on prior neuroimaging findings;
  • Been prescribed antipsychotic/antiepileptic medications;
  • 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;
  • Contraindications to MRI scanning, including:
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California-San Diego

San Diego, California, 92161, United States

Location

University of California San Francisco

San Francisco, California, 94121, United States

Location

Universtiy of Miami Health System

Miami, Florida, 33136, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Pittsburgh Medical College

Pittsburgh, Pennsylvania, 15203, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Tanwar M, Miller E, Tsiouris AJ, Nguyen J, Agarwal V, Marinelli L, Erdemir GA, Shetty T. White Matter Hyperintensities on High-Resolution 3-T MRI: Frequency in Mild Traumatic Brain Injury and Associations With Clinical Markers-A Prospective Controlled Multicenter Study. AJR Am J Roentgenol. 2025 May;224(5):e2432274. doi: 10.2214/AJR.24.32274. Epub 2025 Feb 19.

    PMID: 39969142DERIVED

MeSH Terms

Conditions

Brain ConcussionBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Results Point of Contact

Title
John Strohmeyer
Organization
GE Healthcare
john.strohmeyer@ge.com
609-865-7423

Study Officials

  • Victor Miranda, MD

    GE Healthcare

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2015

First Posted

September 22, 2015

Study Start

November 1, 2015

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

September 10, 2019

Results First Posted

September 10, 2019

Record last verified: 2019-09

Locations

US(7)