Imaging of Traumatic Brain Injury

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01196299

Acronym

Imaging of TBI

Enrollment

150

Registered

2010-09-08

Start date

2010-03-21

Completion date

2015-09-05

Last updated

2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

diffusion tensor imaging, magnetic resonance spectroscopy, traumatic brain injury, Metabolite changes, Cerebral perfusion, Hemorrhagic burden

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of advanced MR imaging markers	18 months post-injury	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.

Secondary

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

Countries

United States

Outcome results