NCT03999164Active, not recruitingPhase 1
Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy
Imaging of Glial Activation and Risk for Post-Traumatic Epilepsy
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 24 Jun 2019
- Start date
- 1 Feb 2020
- Primary completion date
- 14 Aug 2025
- Lead sponsor
- University of California, Davis
- Diseases
- Epilepsy
- NCT number
- NCT03999164
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 1 Feb 2020 to the primary completion date, 14 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to undergo MRI at 14 days (± 4 days) due to bullet, metal implant, or pacemaker
Other illness
- Pre-existing Neurodegenerative Disorders
- Pre-existing epilepsy/seizure disorder
- Pre-existing dementia
Age
- Ages 17 years or younger
Other
- Low-affinity TSPO binding profile
- 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
- Pregnancy
- Isolated anoxic brain injury
- Incarceration present or pending
- Devastating cervical spine injury
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.