Imaging brain inflammation to assess risk of post-traumatic epilepsy
Imaging of Glial Activation and Risk for Post-Traumatic Epilepsy
This study is testing if brain scans can help predict the risk of developing epilepsy after a moderate to severe brain injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT03999164 on ClinicalTrials.gov |
What this trial studies
This study evaluates the time course of neuroinflammation in the brain following moderate to severe traumatic brain injury (TBI) using positron emission tomography (PET) scans. Patients will undergo PET imaging at two weeks and two months post-injury to measure levels of neuroinflammation, specifically focusing on glial activation through the binding of a radiotracer. The study aims to correlate these imaging results with the risk of developing post-traumatic epilepsy (PTE), addressing a significant gap in understanding the biological mechanisms behind PTE. By utilizing PET imaging, the study seeks to provide insights that could lead to better prevention and treatment strategies for patients at risk of PTE.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-100 who have experienced an acute traumatic brain injury with a Glasgow Coma Scale score between 3 and 13.
Not a fit: Patients with low-affinity TSPO binding profiles or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention of post-traumatic epilepsy in patients who have suffered a traumatic brain injury.
How similar studies have performed: While there is limited direct evidence from similar studies, the use of PET imaging to assess neuroinflammation is a promising approach that has shown potential in related research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- University of California, Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Ryan M Martin, MD
- Email: rymartin@ucdavis.edu
- Phone: 9167343650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.