Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy (NCT03999164) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy
United States30 participantsStarted 2020-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury
Timeframe: 2 weeks
2
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury