TBI (Traumatic Brain Injury)NCT05205174
Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
A study testing depth electrodes in people with TBI (Traumatic Brain Injury), run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- depth electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 3 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI
Who cannot join
- Contaminated scalp lacerations
- Known systemic infection
- Non-English speaking
- Fixed, uncorrectable coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
David Darrow, MD MPH, 612-624-6666, rnl@umn.edu
Study Coordinator, 612-873-9113, rnl@umn.edu
About this study
Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.
Read the 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- depth electrodes
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depth electrodesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: depth electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start3 Apr 2025
- Primary completion3 Dec 2028 (estimated)
- Study completion3 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205174
- Sponsor's protocol ID
- IRB-FY2021-251
- Status last verified
- Feb 2026
- First submitted
- 14 Dec 2021
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05205174
- Acronym / sponsor ID
- IRB-FY2021-251
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 3 Dec 2028 (estimated)
- Study completion
- 3 Dec 2030 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Other | Device: depth electrodesThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient recommended to undergo EVD placement for the monitoring and possible treatment of Intracranial pressure (ICP) after TBI
Key exclusion criteria (4 listed)
- Contaminated scalp lacerations
- Known systemic infection
- Non-English speaking
- Fixed, uncorrectable coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depth electrodesThe 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. | Device | Feasibility |
Primary outcome
Detecting CSDs in TBI patients
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Darrow, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing depth electrodes in people with TBI (Traumatic Brain Injury), run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Darrow, MD (612-624-6666, rnl@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting CSDs in TBI patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.