Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

NCT05205174 | Recruiting DMC FDA Device

• 1 other identifier: IRB-FY2021-251
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

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.

  2 years

Study Arms (1)

Feasibility

OTHER

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.

Device: depth electrodes

Interventions

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.

Feasibility

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Darrow, MD

CONTACT

612-624-6666; rnl@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 25, 2022
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 3, 2028
• Study Completion (Estimated): December 3, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)