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NCT Number: NCT07842458

Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contaminated scalp lacerations
  • Known systemic infection
  • Non-English speaking
  • Fixed, uncorrectable coagulopathy
  • Pregnant, minors, or wards of the state

Treatment and study plan

A multi-contact depth electrode

Device

Placement of a multi-contact depth electrode through the same burr hole created with a twist drill for clinically indicated EVD placement in TBI patients. The electrode will be positioned adjacent to the EVD catheter and connected to a stimulator/recording system to deliver biphasic, charge- balanced pulses (1-6 mA, 60-1000 µs) between adjacent contacts less than or equal to once every 3 seconds (0.33 Hz) while recording evoked cortical reverberation responses.

Other names: A stimulator/recording system, Cerestim

Primary outcomes

  1. Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis

    Time frame: through study completion, up to two years

    A depth electrode is placed through the existing external ventricular drain (EVD) burr hole and used to deliver intracortical stimulation and record cortical reverberation (CR) responses. A participant is counted as meeting the endpoint if ≥24 cumulative hours of CR recording are obtained that pass predefined criteria and are judged suitable for feature extraction.

Secondary outcomes

  1. Amplitude of Cortical Reverberation Response

    Time frame: through study completion, up to two years

    Peak amplitude of the CR response evoked by intracortical stimulation, extracted from the recorded signal by an automated feature-extraction algorithm and reported in microvolts.

  2. Duration of Cortical Reverberation Response

    Time frame: through study completion, up to two years

    Duration of the CR response evoked by intracortical stimulation, defined as the interval from response onset to return to baseline, extracted by an automated feature-extraction algorithm and reported in milliseconds.

  3. Decay Slope of Cortical Reverberation Response

    Time frame: through study completion, up to two years

    Rate of amplitude decay of the CR response evoked by intracortical stimulation, extracted by an automated feature-extraction algorithm and reported in microvolts per millisecond.

  4. Latency of Cortical Reverberation Response

    Time frame: through study completion, up to two years

    Interval from delivery of the intracortical stimulus to onset of the CR response, extracted by an automated feature-extraction algorithm and reported in milliseconds.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Samuel Cramer

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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