OPTIMA-TBI Pilot Study

• Status: Completed
• Trial end date: 2021-07-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan

Criteria

Inclusion Criteria:

• Individuals presenting to the emergency department (ED) within 24 hours of injury, who meet the American Congress of Rehabilitation Medicine (ACRM)'s definition of having mild traumatic brain injury (mTBI) will be eligible

• The ACRM defines mTBI as a traumatically-induced physiological disruption of brain function as a consequence of the head being struck, striking an object, or undergoing an acceleration/deceleration movement without direct external head trauma and resulting in at least one of the following:

• any period of loss of consciousness (LOC)

• any loss of memory for events immediately before or after the injury

• any alteration in mental state at the time of the injury (eg, feeling dazed, disoriented, or confused)

• focal neurological deficit(s) that may or may not be transient

Exclusion Criteria:

• GCS<13 at any time during ED stay.

• Significant polytrauma including: bony fracture or solid organ injury

• Study medication cannot be administered within 24 hours of injury

• Patient cannot be relied on to complete follow-up (i.e. no reliable telephone number, substance dependence, homeless)

• Cannot communicate in English

• Take an anticoagulant (coumadin or a novel oral anticoagulant) daily

• Age less than 18 years or greater than 65 years

• Patients already taking fish oil supplements daily

• History of cognitive impairment

• Allergic to fish/fish oil

• Pregnant women (self-reported)