Imaging of Traumatic Brain Injury (Imaging of TBI)

Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients

This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.

It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury

Detailed Description

The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.

Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University Of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with head trauma ranging from mild to severe.

Description

Inclusion Criteria:

• Age 18 or older
• Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
• Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.

Exclusion Criteria:

• History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
• History of Stroke
• History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
• History of Brain Tumor
• Status post trauma due to asphyxiation
• Preexisting contraindications for Magnetic Resonance Imaging (MRI)
• Active Duty Military Status
• Police custody or prisoner status
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Severe Traumatic Brain Injury Group; The severe traumatic brain injury group are patients admitted to the study with an admission GCS between 3 and 8.
Moderate Head Injury Group; The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12.
Mild Head Injury Group; The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15.
Healthy Volunteer Group; Healthy volunteers will be selected to match the age distribution of the TBI groups. They must be absent of any abnormal radiological findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of advanced MR imaging markers	Systematically study the imaging markers obtained from novel MRI techniques (diffusion tensor imaging (DTI), susceptibility-weighted imaging (SWI), MR spectroscopy, resting state MRI, and arterial spin labeling) and assess the markers for sensitivity.	18 months post-injury

Secondary Outcome Measures

Outcome Measure	Time Frame
level of cognitive function	18 months post-injury
extent of disability	18 months post-injury
level of orientation	18 months post-injury
level of functional independence	18 months post-injury

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Rao P Gullapalli, PhD, University of Maryland Medical School

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2010
• Primary Completion (ACTUAL): April 17, 2015
• Study Completion (ACTUAL): September 5, 2015

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (ESTIMATE): September 8, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: magnetic resonance spectroscopy; traumatic brain injury; diffusion tensor imaging; Cerebral perfusion; Metabolite changes; Hemorrhagic burden
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HP-00040713; W81XWH-08-1-0725 (OTHER_GRANT: USA Med Research and Materiel Command)