Epilepsy, Post-TraumaticPhase 1NCT03999164
Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy
A Phase 1 study testing [18F]DPA-714 Positron Emission Tomography Scan in people with Epilepsy, Post-Traumatic, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Epilepsy, Post-Traumatic
- What is being tested?
- [18F]DPA-714 Positron Emission Tomography Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 14 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Pre-existing Neurodegenerative Disorders
- Pre-existing epilepsy/seizure disorder
- Pre-existing dementia
- Isolated anoxic brain injury
- Incarceration present or pending
- Devastating cervical spine injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
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.
Read the detailed description
The development of post-traumatic epilepsy (PTE) is associated with neurobiological, cognitive, psychological, and social consequences that are far-reaching for the patient. Despite our keen awareness of this significant public health issue, little is known regarding the biological mechanisms leading to PTE. One plausible mechanism is that unchecked neuroinflammation, a process that occurs in animal and human models of both traumatic brain injury (TBI) and epilepsy, leads to altered synaptic transmission and neuronal excitability. However, the direct relationship between neuroinflammation and PTE has been difficult to ascertain from pre-clinical studies as they may not accurately reflect the human condition, as few animal models can induce the progression of PTE without a pharmacological enhancer and are predominately limited to studies of mild-to-moderate TBI given high animal mortality rates from more severe injuries. Measurements of neuroinflammation in human TBI and epilepsy has also proven difficult without invasive monitoring or post-mortem evaluations, and measurements of inflammatory mediators in blood or serum may not meaningfully reflect the extent of neuroinflammation.
Encouragingly though, positron emission tomography (PET) can be used to measure the degree of in vivo glial activation in the central nervous system through radiotracer binding of the translocator protein (TSPO), serving as a surrogate of neuroinflammation. Minimally expressed in the uninjured brain, TSPO binding is increased in a number of brain disorders associated with neuroinflammation, including Alzheimer's disease, ischemic stroke, recurrent head trauma in football, brain metastases, TBI, and epilepsy, and is expressed predominately by activated microglia, the main mediators of neuroinflammation. Currently, no pre-clinical or clinical study has analyzed the relationship between glia activation, as measured by TSPO PET, and the risk for developing PTE. Accordingly, we plan to use [18F]DPA-714 to characterize neuro-inflammation following moderate-to-severe TBI in order to better understand the temporal time course of neuro-inflammation following injury and its potential role in epileptogenesis.
- Conditions
- Epilepsy, Post-Traumatic
- Being tested
- [18F]DPA-714 Positron Emission Tomography Scan
- Keywords
- neuroinflammation, activated microglia, TSPO, Traumatic Brain Injury, TBI, Positron emission tomography
- Medical subject headings
- Epilepsy, Post-Traumatic, Neuroinflammatory Diseases, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]DPA-714 Positron Emission Tomography ScanDrug
All patients will undergo a [18F]DPA-714 PET scan of the brain 2 weeks and 2 months following moderate to severe traumatic brain injury to quantify neuroinflammation.
| Study group | Role | What they receive |
|---|---|---|
| Moderate to Severe Traumatic Brain Injury | Experimental | All patients will undergo a [18F]DPA-714 PET scan of the brain 2 weeks and 2 months following moderate to severe traumatic brain injury to quantify neuroinflammation. Receives: Drug: [18F]DPA-714 Positron Emission Tomography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury
Measured: 2 weeks
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury
Measured: 2 months
Secondary outcomes (3)
Frequency of early seizures, epileptiform discharges, and post-traumatic epilepsy
Measured: Admission - two years
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).
Measured: 3 and 6 months
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Feb 2020
- Primary completion14 Aug 2025
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999164
- Sponsor's protocol ID
- 1437948
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Glial Activation and Risk for Post-Traumatic Epilepsy
- ClinicalTrials.gov ID
- NCT03999164
- Acronym / sponsor ID
- 1437948
- Conditions
- Epilepsy, Post-Traumatic
- Keywords
- neuroinflammation, activated microglia, TSPO, Traumatic Brain Injury, TBI, Positron emission tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of post-traumatic epilepsy (PTE) is associated with neurobiological, cognitive, psychological, and social consequences that are far-reaching for the patient. Despite our keen awareness of this significant public health issue, little is known regarding the biological mechanisms leading to PTE. One plausible mechanism is that unchecked neuroinflammation, a process that occurs in animal and human models of both traumatic brain injury (TBI) and epilepsy, leads to altered synaptic transmission and neuronal excitability. However, the direct relationship between neuroinflammation and PTE has been difficult to ascertain from pre-clinical studies as they may not accurately reflect the human condition, as few animal models can induce the progression of PTE without a pharmacological enhancer and are predominately limited to studies of mild-to-moderate TBI given high animal mortality rates from more severe injuries. Measurements of neuroinflammation in human TBI and epilepsy has also proven difficult without invasive monitoring or post-mortem evaluations, and measurements of inflammatory mediators in blood or serum may not meaningfully reflect the extent of neuroinflammation.
Encouragingly though, positron emission tomography (PET) can be used to measure the degree of in vivo glial activation in the central nervous system through radiotracer binding of the translocator protein (TSPO), serving as a surrogate of neuroinflammation. Minimally expressed in the uninjured brain, TSPO binding is increased in a number of brain disorders associated with neuroinflammation, including Alzheimer's disease, ischemic stroke, recurrent head trauma in football, brain metastases, TBI, and epilepsy, and is expressed predominately by activated microglia, the main mediators of neuroinflammation. Currently, no pre-clinical or clinical study has analyzed the relationship between glia activation, as measured by TSPO PET, and the risk for developing PTE. Accordingly, we plan to use [18F]DPA-714 to characterize neuro-inflammation following moderate-to-severe TBI in order to better understand the temporal time course of neuro-inflammation following injury and its potential role in epileptogenesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe Traumatic Brain Injury | Experimental | Drug: [18F]DPA-714 Positron Emission Tomography ScanAll patients will undergo a [18F]DPA-714 PET scan of the brain 2 weeks and 2 months following moderate to severe traumatic brain injury to quantify neuroinflammation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]DPA-714 Positron Emission Tomography ScanAll patients will undergo a [18F]DPA-714 PET scan of the brain 2 weeks and 2 months following moderate to severe traumatic brain injury to quantify neuroinflammation. | Drug | Moderate to Severe Traumatic Brain Injury |
Primary outcome
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury
Time frame: 2 weeks
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury
Time frame: 2 months
3 secondary outcomes
Frequency of early seizures, epileptiform discharges, and post-traumatic epilepsy
Time frame: Admission - two years
Modified Rankin Scale
Time frame: 3 and 6 months
Quantify the association between contusion volume and adjacent cerebral edema with [18F]DPA-714 binding on PET scans
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]DPA-714 Positron Emission Tomography Scan in people with Epilepsy, Post-Traumatic, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.