Advanced MRI Applications for Mild Traumatic Brain Injury (TBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT02070588
First received: February 18, 2014
Last updated: February 23, 2014
Last verified: February 2014
  Purpose

This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), 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.

Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").


Condition Intervention
Mild Traumatic Brain Injury
Traumatic Brain Injury
Device: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Advanced MRI Applications for Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • mTBI progression indicated by clinical neurological characteristics, MRI images, and quantitative MRI data from novel software [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).


Secondary Outcome Measures:
  • Subject demographics [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.

  • Operator set MRI parameters [ Time Frame: Per-patient 1 to 3 months, until dataset completion 1 yr ] [ Designated as safety issue: No ]
    To record operator-adjusted parameters of the novel software on the MRI system


Estimated Enrollment: 500
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diagnostic TBI
MR Diagnostic
Device: MRI
Other Names:
  • Discovery MR750 & Discovery MR750w scanners
  • Investigation software
  • Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be aged ≥15 and ≤50 years old at the time of enrollment;
  • Be diagnosed with mTBI within the past 72 hours, according to the standard diagnostic procedures at the investigational site;
  • Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors

Exclusion Criteria:

  • 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 recreational drug usage in past 10 years;
  • History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  • Current primary Axis I or II psychiatric disorder
  • 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, psychotropic, or antiepileptic medication usage
  • Contraindications to MRI scanning, including current or suspected pregnancy, claustrophobia, anxiety disorders, and any other conditions, as determined by the investigator, that may impact the subject's ability to safely undergo MRI examination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070588

Contacts
Contact: Teena Shetty, MD +1 212-774-2138 shettyt@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 08540
Principal Investigator: Teena Shetty, MD         
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02070588     History of Changes
Other Study ID Numbers: 114-2013-GES-0017
Study First Received: February 18, 2014
Last Updated: February 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
TBI
mTBI
MR
MRI
Pulse Sequences
NFL

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014