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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

Must not have

Isolated anoxic brain injury

Devastating cervical spine injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have suffered a brain injury due to lack of oxygen.

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I have a severe injury to my neck's spine.

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I am 17 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Modified Rankin Scale

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met