Depth Electrode Monitoring for Traumatic Brain Injury

Overseen By David Darrow, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Contaminated scalp lacerations, Systemic infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests depth electrodes, a type of monitoring device, to determine if they can detect changes in brain activity, known as Cortical Spreading Depolarizations (CSD), after a traumatic brain injury (TBI) requiring surgery. The researchers aim to discover if these electrodes and new analysis methods can effectively monitor brain health in TBI patients. Individuals who have experienced a TBI and require a procedure to monitor brain pressure may qualify for this study. However, the trial excludes those with certain scalp injuries, infections, or blood disorders. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance monitoring techniques for future TBI patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that depth electrodes are safe for monitoring traumatic brain injury?

Research has shown that depth electrodes have been safely used in people, particularly for epilepsy. These electrodes help doctors detect brain activity that standard methods cannot capture. Although risks such as infection and bleeding exist, serious complications are rare. While more research is needed to fully understand their use for traumatic brain injury, their successful application in other conditions provides some safety reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using depth electrodes for traumatic brain injury (TBI) because they offer a novel way to monitor brain activity directly. Unlike standard imaging techniques like CT or MRI scans, depth electrodes can detect cortical spreading depolarizations (CSDs), which are critical in understanding brain injuries. This approach could lead to earlier interventions and more targeted treatments, potentially improving outcomes for TBI patients.

What evidence suggests that depth electrodes are effective for monitoring traumatic brain injury?

Research has shown that depth electrodes excel at detecting brain activity that other methods might miss. In one study, depth electrodes recorded 96% of seizure events, while another type of electrode recorded only 52%. This demonstrates their high sensitivity in detecting brain activity. In this trial, researchers will use depth electrodes to monitor traumatic brain injuries (TBIs) and identify specific brain patterns, such as spreading depolarizations (SDs), which are linked to worse outcomes. Using depth electrodes could more effectively identify these patterns, potentially leading to better care for TBI patients. Additionally, a study using depth electrodes for over 2,600 hours reported no complications like bleeding or infection, demonstrating their safety. ^{2 3 4 6 7}

Who Is on the Research Team?

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for patients who need a procedure called EVD placement to monitor and possibly treat high brain pressure after a traumatic brain injury. It's not for those with systemic infections, non-English speakers, uncorrectable blood clotting disorders, or contaminated scalp wounds.

Inclusion Criteria

I am advised to have a procedure to monitor and possibly treat brain pressure after a brain injury.

Exclusion Criteria

I have a permanent blood clotting disorder.

I have a known infection in my body.

I have a dirty cut on my head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Placement of a depth electrode during standard of care EVD placement for ECoG recordings

Immediate (during surgery)

1 visit (in-person, surgical)

Monitoring

ECoG recordings are reviewed to understand the association between cortical spreading depression and pathological findings

2 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Depth electrodes

Trial Overview

The study is testing the use of depth electrodes to detect Cortical Spreading Depolarization (CSD), which are waves of brain activity that may occur after a traumatic brain injury and require neurosurgical intervention.

How Is the Trial Designed?

Group I: Feasibility Experimental Treatment 1 Intervention

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.

Depth electrodes is already approved in United States, European Union for the following indications:

Approved in United States as Depth electrodes for:

• Epilepsy diagnosis and treatment
• Parkinson's disease treatment
• Essential tremor treatment
• Research in traumatic brain injury

Approved in European Union as Depth electrodes for:

• Epilepsy diagnosis and treatment
• Parkinson's disease treatment
• Essential tremor treatment
• Research in various neurological conditions

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The study provides a detailed description and video guide on the implantation technique for depth electrodes using the stereotactic Leksell frame, which is increasingly used in epilepsy centers for intracranial monitoring.

Neurosurgeons can benefit from the technical nuances and potential pitfalls highlighted in this guide, improving the safety and efficacy of depth electrode implantation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operative Nuances of Stereotactic Leksell Frame-Based Depth Electrode Implantation. Joswig, H., Benson, CM., Parrent, AG., et al.[2019]

The foramen ovale electrode (FOE) technique is a safe and effective method for lateralizing seizure onset in patients with bilateral mesiotemporal lobe epilepsy, as demonstrated in a study of 12 patients, where 78% of those who underwent surgery became seizure-free after treatment.

FOE implantation provides clear seizure onset data that is often missed by extracranial EEGs, making it a reliable alternative to more invasive methods like depth electrodes and subdural grids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of foramen ovale electrodes in presurgical evaluation of intractable complex partial seizures. Shih, YH., Yiu, CH., Huang, CI.[2015]

In a study of 452 electrode implantations in 420 patients with drug-resistant focal epilepsy, subdural electrodes were associated with a significantly higher risk of symptomatic hemorrhages (9.9%) compared to depth electrodes (0.3%).

Despite the higher risk of complications with subdural electrodes, the overall rates of persistent neurological deficits were low (1.3%), indicating that both subdural and depth electrode implantation are generally safe options for intracranial EEG exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of subdural and depth electrode implantations in invasive EEG exploration of drug-resistant focal epilepsy. Männlin, J., San Antonio-Arce, V., Reinacher, PC., et al.[2023]

In a study of 115 patients, the insertion of intracerebral depth electrodes (IDEs) was found to be safe, with only five significant complications reported and no permanent neurological deficits associated with the procedure.

There was no evidence of new epileptogenic areas or verbal memory deficits following IDE implantation, suggesting that IDEs do not adversely affect seizure outcomes or cognitive functions in patients undergoing evaluation for epilepsy surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of intrahippocampal depth electrodes for presurgical evaluation of patients with intractable epilepsy. Fernández, G., Hufnagel, A., Van Roost, D., et al.[2019]

In a review of 170 patients undergoing intracranial depth electrode recordings, 85% had a surgically treatable focus identified, indicating high efficacy of the technique for diagnosing epilepsy.

The procedure had low overall morbidity, with no deaths or permanent neurological deficits, although some patients experienced transient neuropsychological issues, such as postictal psychosis, highlighting the need for careful monitoring during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity of chronic recording with intracranial depth electrodes in 170 patients. Espinosa, J., Olivier, A., Andermann, F., et al.[2018]

A new method for obtaining intracranial EEG and depth recordings of somatosensory evoked potentials (SEPs) was successfully tested in baboons using a directable microcatheter placed in the middle cerebral artery.

This technique revealed thalamic-origin waves in depth recordings that were not detectable in surface recordings, offering greater informational gain while being less invasive than traditional depth recording methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Depth EEG and evoked potentials using an intravascular catheter electrode in the baboon]. Reuter, BM., Brassel, F., Linke, DB., et al.[2006]

Intra-cortical electrodes can reliably detect spreading depolarization events in both animal models and human patients, suggesting a new method for monitoring brain activity after injury.

This technique allows for electrode placement via a burr hole instead of requiring a craniotomy, making it a safer and less invasive option for monitoring brain injuries and understanding their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of spreading depolarization with intraparenchymal electrodes in the injured human brain. Jeffcote, T., Hinzman, JM., Jewell, SL., et al.[2021]

In a study of 317 electrode implantation procedures for epilepsy surgery, subdural electrodes (SDE) were associated with a higher rate of postoperative abnormalities, including hemorrhage and extraaxial collections, compared to depth electrodes (DE), with 47.9% of SDE procedures showing abnormalities versus 25.2% for DEs (p < 0.001).

Despite the higher rate of abnormalities with SDEs, there was no significant difference in clinically significant complications between SDEs (9.1%) and DEs (6.3%, p = 0.37), indicating that intracranial monitoring remains a safe and effective method for identifying seizure foci.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of subdural and depth electrodes in 269 patients undergoing 317 procedures for invasive monitoring in epilepsy. Schmidt, RF., Wu, C., Lang, MJ., et al.[2017]

A new depth EEG electrode design has been developed that allows for safe insertion and artifact-free recordings, enhancing the ability to localize seizure origins in epilepsy patients.

In a study involving seven patients over 2600 hours of implantation, the electrode showed no complications such as hemorrhage, edema, or infection, and it provided accurate positioning within critical brain areas like the amygdala and hippocampus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a depth electroencephalography electrode. Maxwell, RE., Gates, JR., Fiol, ME., et al.[2019]

In a study of 12 pediatric patients with neocortical epilepsy, the use of supplemental depth electrodes significantly improved the identification of the ictal onset zone, leading to more targeted surgical resections.

After surgery, 75% of the patients became seizure-free, demonstrating that depth electrodes can enhance surgical outcomes by allowing for more precise interventions while minimizing the extent of tissue resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and utility of supplemental depth electrodes for localizing the ictal onset zone in pediatric neocortical epilepsy. Kim, H., Lee, C., Knowlton, R., et al.[2011]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10669380/

Combined Depth and Subdural Electrodes for Lateralization of ...

Collectively, depth electrodes recorded 96% of seizure events, whereas subdural electrodes captured 52% of them. To delineate further, subdural ...

2.

withpower.com

withpower.com/trial/phase-brain-injuries-traumatic-11-2021-3af8c

Depth Electrode Monitoring for Traumatic Brain Injury

In a study involving seven patients over 2600 hours of implantation, the electrode showed no complications such as hemorrhage, edema, or infection, and it ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05205174

Study Details | NCT05205174 | Depth Electrode Detection ...

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 ...

4.

nature.com

nature.com/articles/s43856-023-00344-3

Noninvasive and reliable automated detection of spreading ...

Increasing evidence shows that SDs are associated with poor clinical outcomes in traumatic brain injuries (TBIs), strokes, and hemorrhages4,5,6, ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1059131116300644

Invasive seizure monitoring in the critically-Ill brain injury ...

Depth electrodes allow detection of seizures not visible on scalp recordings. Further research is needed to confirm the clinical relevance of depth-only ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5505252/

Invasive seizure monitoring in the critically-Ill brain injury ...

Depth electrodes allow detection of seizures not visible on scalp recordings. Further research is needed to confirm the clinical relevance of ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1111/ene.16208

Combined depth and scalp electroencephalographic ...

In addition, dEEG was reported to detect many seizures not readily apparent on scEEG; 43% of seizures or periodic discharges (PDs) were seen ...