Imaging of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— Imaging of TBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196299
• Other study ID #: HP-00040713
• Secondary ID: W81XWH-08-1-0725
• Status: Completed
• Start date: March 21, 2010
• Est. completion date: September 5, 2015

Study information

• Verified date: July 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 5, 2015
• Est. primary completion date: April 17, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	level of cognitive function		18 months post-injury
Secondary	extent of disability		18 months post-injury
Secondary	level of orientation		18 months post-injury
Secondary	level of functional independence		18 months post-injury