Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy

NCT03999164 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 1437948
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy, Post-Traumatic

Keywords

neuroinflammation; activated microglia; TSPO; Traumatic Brain Injury; TBI; Positron emission tomography

Outcome Measures

Primary Outcomes (2)

• Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury

  2 weeks

• Quantification of [18F]DPA-714 binding in the brain following moderate to severe traumatic brain injury

  2 months

Secondary Outcomes (3)

• Frequency of early seizures, epileptiform discharges, and post-traumatic epilepsy

  Admission - two years

• Modified Rankin Scale

  3 and 6 months

• Quantify the association between contusion volume and adjacent cerebral edema with [18F]DPA-714 binding on PET scans

  2 weeks

Study Arms (1)

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.

Drug: [18F]DPA-714 Positron Emission Tomography Scan

Interventions

[18F]DPA-714 Positron Emission Tomography Scan DRUG

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.

Moderate to Severe Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Epilepsy, Post-Traumatic; Neuroinflammatory Diseases; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: February 1, 2020
• Primary Completion: August 14, 2025
• Study Completion (Estimated): August 14, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)