Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

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

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Device: depth electrodes

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Darrow, MD; Phone Number: 612-624-6666; Email: rnl@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin County Medical Center
      • Contact: David Darrow, MD MPH; Phone Number: 612-624-6666; Email: rnl@umn.edu
      • Contact: Study Coordinator; Phone Number: 612-873-9113; Email: rnl@umn.edu
      • Sub-Investigator: David Darrow, MD MPH
      • Principal Investigator: Samual Cramer, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: David Darrow, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: IRB-FY2021-251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No