Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

University of Minnesota (UMN)

Status: Enrolling

Conditions: TBI (Traumatic Brain Injury)

Treatments: Device: depth electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT05205174

IRB-FY2021-251

Details and patient eligibility

About

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

Full description

During the standard of care External Ventricular Drain (EVD) placement, a depth electrode with minimal modification to the standard surgical procedure will be placed. This will allow electrocorticogram (ECoG) recordings. An ECoG will be reviewed by a study Neurosurgeon to understand the association between cortical spreading depression and pathological findings on imaging. The recordings help create a novel algorithm in order to detect CSD's. This may ultimately provide significant benefit to society through the diagnosis and treatment of secondary injury associated with traumatic brain injury.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Contaminated scalp lacerations
• Known systemic infection
• Non-English speaking
• Fixed, uncorrectable coagulopathy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Feasibility

Other group

Description:

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.

Treatment:

Device: depth electrodes