Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
Primary Purpose
TBI (Traumatic Brain Injury)
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
depth electrodes
Sponsored by
About this trial
This is an interventional other trial for TBI (Traumatic Brain Injury)
Eligibility Criteria
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
Sites / Locations
- Hennepin County Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Feasibility
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05205174
First Posted
December 14, 2021
Last Updated
January 24, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05205174
Brief Title
Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
Official Title
Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 3, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minnesota
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feasibility
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
depth electrodes
Intervention Description
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 Information:
Title
Detecting CSDs in TBI patients
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Darrow, MD
Phone
612-624-6666
Email
rnl@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD MPH
Phone
612-624-6666
Email
rnl@umn.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
612-873-9113
Email
rnl@umn.edu
First Name & Middle Initial & Last Name & Degree
David Darrow, MD MPH
First Name & Middle Initial & Last Name & Degree
Samual Cramer, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
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