Mild Traumatic Brain Injury Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01688869

Acronym

mTBI

Enrollment

Registered

2012-09-20

Start date

2012-04-30

Completion date

2015-01-31

Last updated

2022-04-25

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

Conditions

Brain Injury, Traumatic

Keywords

brain concussion

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results