Imaging of Traumatic Brain Injury (Imaging of TBI)

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Traumatic Brain Injury

Study type: Observational

Funder types: Other

Identifiers

NCT01196299

HP-00040713

W81XWH-08-1-0725 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 4 patient groups

Severe Traumatic Brain Injury Group

Description:

The severe traumatic brain injury group are patients admitted to the study with an admission GCS between 3 and 8.

Moderate Head Injury Group

Description:

The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12.

Mild Head Injury Group

Description:

The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15.

Healthy Volunteer Group

Description:

Healthy volunteers will be selected to match the age distribution of the TBI groups. They must be absent of any abnormal radiological findings.