Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Minnesota

About this trial

Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contaminated scalp lacerations

Known systemic infection

Non-English speaking

Fixed, uncorrectable coagulopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • depth electrodes

    Device

    The study will be conducted at a single center, in TBI patients requiring neurosurgical intervention in the form of EVD placement. During neurosurgical intervention at the bedside in the Intensive Care Unit (ICU), a single depth electrode will be placed in the brain adjacent to the EVD catheter in the same burr hole. After EVD and depth electrode placement, continuous recording of ECoG activity as well as relevant physiological parameters will be performed for the duration of clinically indicated invasive neuromonitoring in accordance with the standard of care for TBI patients. A single recording station is currently available for data collection, therefore, with an anticipated average recording period of 14 days, the study will take greater than 210 days to complete for a total of 15 patients.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: FeasibilityOther 1 intervention

Trial outcomes

Primary outcomes

1

Detecting CSDs in TBI patients

The primary endpoint is to determine the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients. A single depth electrode will be placed at the same time the EVD is performed. ECoG recordings from each patient will be recorded.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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