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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Jun 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how inflammation in the brain develops after a moderate to severe traumatic brain injury (TBI) and how this inflammation might affect the risk of developing post-traumatic epilepsy, which is a type of seizure disorder that can occur after a head injury. Researchers will use a special imaging test called positron emission tomography (PET) scans to look at the brain's inflammation at two different times: two weeks and two months after the injury. By analyzing the results, the study aims to understand the connection between brain inflammation and the likelihood of experiencing seizures later on.

To participate in this study, individuals must be between 18 and 100 years old and have recently suffered an acute TBI. They need to be able to join the study within 72 hours of their injury and have a specific level of consciousness, as measured by a scale called the Glasgow Coma Scale. Patients with certain types of brain injuries, like hemorrhagic contusions, are eligible, while those with a history of epilepsy, severe cognitive issues, or certain injuries may not qualify. If eligible, participants can expect to undergo the PET scans and contribute valuable information that could help improve understanding and treatment of post-traumatic epilepsy.

Gender

ALL

Eligibility 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