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PET Brain Imaging for Post-Traumatic Epilepsy

Phase 1

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute Traumatic Brain Injury (TBI)

Glasgow Coma Scale (GCS) 3-13 without continuous sedation at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up admission - two years

Awards & highlights

Study Summary

This trial will use PET brain imaging to study how long inflammation persists in the brain after a TBI, in order to better understand the connection between TBI and risk of post-traumatic epilepsy.

Who is the study for?

This trial is for adults aged 18-100 who've had a moderate to severe traumatic brain injury. They should be enrolled within 72 hours of the injury and have specific types of brain damage. People with pre-existing neurological conditions, pregnancy, or metal implants that prevent MRI scans can't participate.Check my eligibility

What is being tested?

[18F]DPA-714 PET scans are being used to track brain inflammation after a traumatic injury at two weeks and two months post-injury. The study aims to link the level of inflammation detected with the risk of developing post-traumatic epilepsy.See study design

What are the potential side effects?

PET scanning is generally safe but may include discomfort from lying still during the scan, allergic reactions to tracers, or exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recently suffered a traumatic brain injury.

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I am partially conscious without needing constant sedation.

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I have bleeding in the front or side parts of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ admission - two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~admission - two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and admission - two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Modified Rankin Scale

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Moderate to Severe Traumatic Brain InjuryExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,553 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are typically associated with [18F]DPA-714 Positron Emission Tomography Scan?

"Our research team at Power has assigned a score of 1 to [18F]DPA-714 Positron Emission Tomography Scan due to the lack of extensive safety and efficacy data present in its Phase 1 trial."

Answered by AI

Could I be accepted as an individual in this clinical trial?

"In this medical study, 30 individuals with impact seizures ages 18 to 100 will be recruited. Applicants must have sustained frontal and/or temporal lobe contusional injuries, penetrating TBI that can support cEEG monitoring or MRI in some cases, an acute traumatic brain injury (TBI), GCS score between 3-13 without continuous sedation at the time of enrollment, admission within 72 hours post-injury, and associated polytrauma such as long bone fractures or blunt abdominal trauma."

Answered by AI

Are there any vacancies available to participants in this experiment?

"As per the information hosted on clinicaltrials.gov, this medical trial is currently looking for participants and has been since February 1st 2020. The listing was last amended in July 6th 2022."

Answered by AI

What is the current population of individuals engaging in this medical research?

"Affirmative. As per clinicaltrials.gov, this case study is currently recruiting volunteers and was initially published on the 1st of February 2020 before being amended most recently on 6th July 2022. Only 30 patients are required across a single site for participation in the trial."

Answered by AI