Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05205174

Conditions

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

depth electrodes

Study Details

Brief summary:

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

Conditions

TBI (Traumatic Brain Injury)

Study ID

NCT05205174

Start date

Apr 3, 2025

Status verified date

Feb, 2026

Completion date

Dec 3, 2030

Anticipated

Primary completion date

Dec 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Feasibility

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.

Interventions

depth electrodes

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.

Primary outcome measure

  • Detecting CSDs in TBI patients [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

David Darrow, MD

612-624-6666rnl@umn.edu

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

David Darrow, MD MPH

612-624-6666rnl@umn.edu

Study Coordinator

612-873-9113rnl@umn.edu

Principal Investigator:

Samual Cramer, MD, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-02-23.