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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01196299
Other study ID # HP-00040713
Secondary ID W81XWH-08-1-0725
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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