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Neurostimulation Device

Depth Electrode Monitoring for Traumatic Brain Injury

N/A

Recruiting

Led By David Darrow, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI

Must not have

Fixed, uncorrectable coagulopathy

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new way of measuring and recording brain activity can help predict and treat a type of brain injury.

Who is the study for?

This trial is for patients who need a procedure called EVD placement to monitor and possibly treat high brain pressure after a traumatic brain injury. It's not for those with systemic infections, non-English speakers, uncorrectable blood clotting disorders, or contaminated scalp wounds.

What is being tested?

The study is testing the use of depth electrodes to detect Cortical Spreading Depolarization (CSD), which are waves of brain activity that may occur after a traumatic brain injury and require neurosurgical intervention.

What are the potential side effects?

While specific side effects aren't listed, depth electrode insertion can potentially cause discomfort at the site of implantation, risk of infection, bleeding in the brain, or seizures.

Eligibility Criteria

Inclusion Criteria

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

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I am advised to have a procedure to monitor and possibly treat brain pressure after a brain injury.

Exclusion Criteria

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

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I have a permanent blood clotting disorder.

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I do not speak English.

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I have a known infection in my body.

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I have a dirty cut on my head.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Detecting CSDs in TBI patients

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: FeasibilityExperimental Treatment1 Intervention

This is a preliminary, prospective interventional study to investigate the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients.

0 / 5Eligibility criteria met