Epilepsy, Post-Traumatic Clinical Trial
Official title:
Imaging of Glial Activation and Risk for Post-Traumatic Epilepsy
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 | Recruiting |
Enrollment | 30 |
Est. completion date | August 14, 2024 |
Est. primary completion date | August 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury | 2 weeks | ||
Primary | Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury | 2 months | ||
Secondary | Frequency of early seizures, epileptiform discharges, and post-traumatic epilepsy | Admission - two years | ||
Secondary | Modified Rankin Scale | All patients will undergo a phone survey at 3 and 6 months post-injury to assess functional outcome using the Modified Rankin Scale. The Modified Rankin Scale measures the degree of disability or dependence in daily activities of patients who have suffered an neurological injury, ranging from 0 (no symptoms) to 6 (dead). | 3 and 6 months | |
Secondary | Quantify the association between contusion volume and adjacent cerebral edema with [18F]DPA-714 binding on PET scans | All patients will undergo multi-modal MRI brain (Fluid-attenuated inversion recovery (FLAIR), susceptibility weighted imaging(SWI), diffusion weighted imaging(DWI)) two weeks post-injury to assess for acute structural abnormalities | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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