Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy

• Status: Recruiting
• Trial end date: 2022-08-14
• Target enrollment: 0
• Participant gender: All

Summary

This study plans to evaluate the time course of inflammation in the brain after a moderate to severe traumatic brain injury using positron emission tomography (PET) brain imaging. Patients will undergo PET scans of the brain at two weeks and two months after injury to measure neuro-inflammation. The results of the PET scans will be analyzed and correlated with the risk of post-traumatic epilepsy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis

Criteria

Inclusion Criteria:

• Acute Traumatic Brain Injury (TBI)

• Age 18-100 are eligible

• Glasgow Coma Scale (GCS) 3-13 without continuous sedation at time of enrollment

• Ability to enroll within 72 hours of injury

• Hemorrhagic contusional injuries to frontal and/or temporal lobes.

• Polytrauma including long bone fractures, blunt trauma, abdominal trauma or similar will be allowed

• Penetrating TBI if continuous electroencephalography (cEEG) is feasible and survival for 2 years is feasible, recognizing that MRI may not be feasible with some forms of penetrating trauma

Exclusion Criteria:

• Low-affinity TSPO binding profile

• Ages 17 years or younger

• Patients with diffuse axonal injury in the absence of hemorrhagic contusions or skull fracture, and isolated epidural hemorrhages that improve after evacuation

• No planned continuous EEG monitoring during injury day 1-7

• Inability to undergo MRI at 14 days (± 4 days) due to bullet, metal implant, or pacemaker

• Pregnancy

• Pre-existing Neurodegenerative Disorders

• Pre-existing epilepsy/seizure disorder

• Pre-existing dementia

• Isolated anoxic brain injury

• Incarceration present or pending

• Devastating cervical spine injury