Mild Traumatic Brain Injury Registry (mTBI)

April 19, 2022 updated by: Wake Forest University Health Sciences
The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are seen in the CMC emergency department who have a clearly defined history of traumatic brain injury that produced at least transient alteration in consciousness, or change in mood, together with one or more persistent symptom lasting longer than one hour after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion, amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be enrolled within 72 hours of the injury.

Description

Inclusion Criteria:

  • Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood
  • Must be awake and alert (Glasgow Coma Scale 13-15)
  • Must be enrolled within 72 hours of injury
  • Must have CT or MRI neuroimaging performed

Exclusion Criteria:

  • Diabetes Mellitus with severe complications
  • Intoxication at time of enrollment
  • Major psychiatric disorder that is poorly controlled
  • Prior stroke
  • History of Social Security defined "disability
  • Uncontrolled Seizure Disorder
  • Incarceration or arrest
  • Concurrent Injury requiring hospitalization
  • Use of anticoagulant drugs
  • Any condition the investigator deems as inappropriate for patient enrollment
  • Personality disorder
  • Heart, liver or kidney failure defined using common clinical practice guidelines
  • Baseline cognitive impairment
  • Homelessness
  • TBI associated with interpersonal violence
  • Pregnancy
  • Long bone fracture requiring surgical stabilization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Mild TBI
Patients who have been diagnosed with a mild brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Lori M Grafton, MD, Wake Forest University Health Sciences
  • Principal Investigator: Michael A Gibbs, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-12-03A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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