Mission Connect Mild Traumatic Brain Injury (TBI) Integrated Clinical Protocol

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury, Post-traumatic Stress Disorder

In brief

The purpose of this study is to improve the ability to diagnose problems after mild traumatic brain injury (MTBI) and to test a drug that may improve the outcome from these injuries. Of the more than 1.5 million people who experience a traumatic brain injury (TBI) each year in the United States, as many as 75% sustain a mild TBI which can cause long-term or permanent impairments/disabilities in a significant proportion of patients. In addition, traumatic brain injury has become a signature injury of the wars in Iraq and Afghanistan. For people with these injuries, it is difficult to determine whether symptoms are due to the head injury or another condition, such as Post-traumatic Stress Disorder. In this project, there are 3 observational studies that involve testing of mental functions and behavior, imaging of the brain with special x-ray procedures, and blood samples to look at glandular function, which may be affected by head injury. A fourth study is a test of a drug, atorvastatin, which may provide protection for injured brain cells and improve outcome. By collecting and analyzing the information from these tests, it will be possible to make the process of diagnosing mild TBI or post traumatic stress disorder (PTSD) more precise, and also to see if atorvastatin is a helpful drug for patients with MTBI.

Key facts

Study ID

NCT01013870

Run by

Baylor College of Medicine

People needed

52

Starts

2010-02-01

Expected to finish

2015-06-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18-50 years
• MTBI subjects: evidence of closed head injury; Glasgow Coma Score 13-15; loss of consciousness < 30 minutes; post-traumatic amnesia < 24 hours; Abbreviated Injury Score </= 3 for any body region; absence of focal lesions on head CT scan
• Orthopedic Injury subjects: evidence of traumatic injury, other than head; Abbreviated Injury Score </= 3 for any body region
• does not require hospitalization for injuries
• visual acuity and hearing adequate to participate in testing
• fluent in either English or Spanish

You may not qualify if…

• Abbreviated Injury Score > 3 for any body region
• any type of penetrating injury
• history of significant pre-existing disease or systemic injuries
• history of schizophrenia or bipolar disorder
• blood alcohol > 200 mL/dL
• left-handed
• existing contraindications for MRI
• claustrophobia
• pregnancy
• exclusions related to atorvastatin, including currently taking any statin drug (atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin), no longer taking a statin drug but history of use within the last six months, previously taking any statin drug at any time but now discontinued due to side effects, taking any medication with known interactions with atorvastatin (cyclosporine, fibric acid derivative, erythromycin, clarithromycin, combination of ritonavir plus saquinavir or lopinavir, niacin in doses exceeding multivitamin dosage, or azole antifungals), active liver disease, history of unexplained persistent elevation of serum transaminases, and hypersensitivity to any component of atorvastatin.

Where it is running

• Baylor College of Medicine/Ben Taub General Hospital — Houston, Texas, United States
• University of Texas Health Science Center at Houston/Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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