Image

Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury

Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement.

Description

Traumatic brain injury (TBI) is a major cause of death and disability and imposes burden on the health-system and society. Beyond the first impact of the injury, secondary brain injury processes, include elevated intracranial pressure (ICP), impaired autoregulation, seizures, and cortical spreading depolarizations (CSDs). These effects drive lesion expansion and worsen outcomes. Observational cohorts show that CSDs are common after severe TBI and that higher CSD burden results in worse recovery.

This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement. EVDs are required to monitor and manage significant intracranial pressure. During standard-of-care EVD placement at the bedside in the intensive care unit (ICU), a single multi-contact depth electrode will be placed adjacent to the EVD catheter through the same burr hole. The electrode will be connected to a stimulator and recording system. Biphasic, charge-balanced intracortical pulses (1-6 mA, 60-1000 µs) will be delivered between adjacent contacts once every 3 seconds (0.33 Hz) for the duration of monitoring. Continuous electrocorticography (ECoG) will be recorded from the same electrode contacts. Recordings will be reviewed daily by a study neurosurgeon or an epileptologist for evidence of electrographic seizure activity. CR responses will be analyzed offline to assess feasibility, signal quality, and correlation with concurrent physiologic measures obtained from multimodal monitoring. The duration of study monitoring will be determined by the length of time that invasive neuromonitoring is clinically indicated. The depth electrode will be removed at the bedside once EVD monitoring is discontinued or the patient is discharged from the ICU.

Eligibility

Inclusion Criteria:

  1. 18 years or older
  2. Consenting party must be able to provide written consent in English
  3. Patient recommended to undergo EVD placement for the monitoring and possible treatment of ICP after TBI

Exclusion Criteria:

  1. Contaminated scalp lacerations
  2. Known systemic infection
  3. Non-English speaking
  4. Fixed, uncorrectable coagulopathy
  5. Pregnant, minors, or wards of the state

Study details
    Traumatic Brain Injury

NCT07842458

Samuel Cramer

20 October 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.