RECRUITING

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

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Conditions

Epilepsy, Post-Traumaticneuroinflammationactivated microgliaTSPOTraumatic Brain InjuryTBIPositron emission tomography

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Imaging of Glial Activation and Risk for Post-Traumatic Epilepsy

Quick Facts

Study Start:2020-02-01
Study Completion:2025-08-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03999164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Acute Traumatic Brain Injury (TBI)
  2. * Age 18-100 are eligible
  3. * Glasgow Coma Scale (GCS) 3-13 without continuous sedation at time of enrollment
  4. * Ability to enroll within 72 hours of injury
  5. * Hemorrhagic contusional injuries to frontal and/or temporal lobes.
  6. * Polytrauma including long bone fractures, blunt trauma, abdominal trauma or similar will be allowed
  7. * 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
  1. * Low-affinity TSPO binding profile
  2. * Ages 17 years or younger
  3. * Patients with diffuse axonal injury in the absence of hemorrhagic contusions or skull fracture, and isolated epidural hemorrhages that improve after evacuation
  4. * No planned continuous EEG monitoring during injury day 1-7
  5. * Inability to undergo MRI at 14 days (± 4 days) due to bullet, metal implant, or pacemaker
  6. * Pregnancy
  7. * Pre-existing Neurodegenerative Disorders
  8. * Pre-existing epilepsy/seizure disorder
  9. * Pre-existing dementia
  10. * Isolated anoxic brain injury
  11. * Incarceration present or pending
  12. * Devastating cervical spine injury

Contacts and Locations

Study Contact

Ryan M Martin, MD
CONTACT
9167343650
rymartin@ucdavis.edu

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01
Study Completion Date2025-08-14

Study Record Updates

Study Start Date2020-02-01
Study Completion Date2025-08-14

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Epilepsy, Post-Traumatic