NCT01196299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2015

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

5.1 years

First QC Date

September 3, 2010

Last Update Submit

July 18, 2022

Conditions

Traumatic Brain Injury

Keywords

diffusion tensor imagingmagnetic resonance spectroscopytraumatic brain injuryMetabolite changesCerebral perfusionHemorrhagic burden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted with head trauma ranging from mild to severe.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Rao P Gullapalli, PhD

    University of Maryland Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

March 21, 2010

Primary Completion

April 17, 2015

Study Completion

September 5, 2015

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

US(1)