Depth Electrode Monitoring for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen by David Darrow, MD MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Disqualifiers: Contaminated scalp lacerations, Systemic infection, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Depth electrodes for Traumatic Brain Injury?

Depth electrodes have been shown to be effective in accurately identifying seizure origins in epilepsy, which suggests they can precisely monitor brain activity. This precision could potentially be beneficial in understanding and treating traumatic brain injuries, although direct evidence for this specific use is not provided. ^{1 2 3 4 5}

Is it safe to use depth electrodes in humans?

Depth electrodes have been used safely in humans for conditions like epilepsy, with some risks such as infection and bleeding, but serious complications are rare. Studies show that with careful monitoring and proper techniques, the procedure is generally safe, though some patients may experience temporary psychological effects. ^{1 4 5 6 7}

How is the treatment using depth electrodes unique for traumatic brain injury?

Depth electrodes are unique because they are inserted directly into the brain to monitor electrical activity, allowing for precise detection of brain events like spreading depolarizations, which are linked to poor outcomes after brain injury. This method provides more detailed information than surface electrodes and can be less invasive than other depth recording techniques. ^{1 3 8 9 10}

Research Team

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Eligibility Criteria

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 do not speak English.

I have a known infection in my body.

Trial Timeline

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

Treatment Details

Interventions

• Depth electrodes (Neurostimulation Device)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hennepin County Medical Center Minneapolis, MN

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1459

Patients Recruited

1,623,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a depth electroencephalography electrode. [2019] Stereo depth electroencephalography (EEG) is of proven benefit in lateralizing and localizing seizure origin in select cases of epilepsy. There are potential hazards and technical considerations inherent with depth EEG, however, that have limited the general applicability of this technique. A new depth EEG electrode with materials and design features that facilitate safe insertion and artifact-free recording has been developed. The design features and technique for inserting the electrode are described. The electrode was evaluated during 2600 hours of implantation and recording in seven patients. With the use of stereotactic techniques, the electrode could be positioned accurately within precise anatomical landmarks such as the amygdaloid nucleus and the hippocampus. After insertion, no hemorrhage or edema was detected along the electrode tracts by third generation computed tomographic scanning. There was no evidence of pyrogenicity or infection. Electrode migration was not observed. A large electrical field could be sampled because of the relatively large surface of the cylindrical depth electrode contacts.

2. United States pubmed.ncbi.nlm.nih.gov

Safety and utility of supplemental depth electrodes for localizing the ictal onset zone in pediatric neocortical epilepsy. [2011] Depth electrodes provide a better sampling of sulci and regions of cortex that lie tangential to the plane of subdural electrodes. The aim of this study was to evaluate the utility of supplemental depth electrodes in the surgical treatment of pediatric patients with neocortical epilepsy.

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Role of foramen ovale electrodes in presurgical evaluation of intractable complex partial seizures. [2015] The value of intracranial electrodes such as depth electrodes and subdural grids for intracranial electroencephalographic (EEG) recording in patients with intractable epilepsies has been well recognized. A new technique, foramen ovale electrode (FOE) implantation, was first introduced by Wieser in 1984 for the lateralization of bilateral mesiotemporal lobe (MTL) onset of seizures.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Morbidity of chronic recording with intracranial depth electrodes in 170 patients. [2018] A consecutive series of 170 patients who have been submitted to intracranial depth electrode recordings is reviewed to assess the overall morbidity of the technique. Most patients had bitemporal and frontal electrodes inserted and were monitored for an average period of 18 days. A surgically amenable focus was found in 85% of the cases. There were 4 cases of infection including 2 cerebral abscesses which required surgical evacuation. One patient with frontal lobe atrophy developed an acute subdural hematoma after electrode implantation. There was no death or neurological deficit in the entire series. Morbidity was encountered mainly in the neuropsychological sphere, several patients having developed transient postictal psychosis after repetitive seizures. Our recording technique has been associated with low surgical morbidity. Patients undergoing depth electrode recordings should be closely monitored to minimize the occurrence of psychotic episodes associated with drug withdrawal and increased seizure frequency.

5. United States pubmed.ncbi.nlm.nih.gov

Safety of intrahippocampal depth electrodes for presurgical evaluation of patients with intractable epilepsy. [2019] Intracerebral depth electrodes are used in preoperative evaluation of selected patients with intractable epilepsies. In spite of their usefulness, safety of depth electrodes is disputed, and the number of insertions is decreasing. This study examined retrospectively possible deleterious effects such as perioperative complications, induction of epileptogenesis, and neuropsychologic deficits.

6. England pubmed.ncbi.nlm.nih.gov

Safety profile of subdural and depth electrode implantations in invasive EEG exploration of drug-resistant focal epilepsy. [2023] To analyze the safety profile of subdural and depth electrode implantation in a large monocentric cohort of patients of all ages undergoing intracranial EEG exploration because of drug resistant focal epilepsy diagnosed and implanted by a constant team of epileptologists and neurosurgeons.

7. United States pubmed.ncbi.nlm.nih.gov

Complications of subdural and depth electrodes in 269 patients undergoing 317 procedures for invasive monitoring in epilepsy. [2017] Intracranial monitoring is fundamental to epilepsy surgery, with reported complication rates of 3-17%. We aimed to assess the differences in complication rates between subdural and depth electrodes.

8. United States pubmed.ncbi.nlm.nih.gov

Operative Nuances of Stereotactic Leksell Frame-Based Depth Electrode Implantation. [2019] For intracranial electroencephalographic monitoring, stereotactically implanted depth electrodes are increasingly used at epilepsy centers around the world.

9. Germany pubmed.ncbi.nlm.nih.gov

[Depth EEG and evoked potentials using an intravascular catheter electrode in the baboon]. [2006] Obtaining an intracranial EEG, as well as a depth recording of the somatosensory evoked potentials, via a vascular approach are described. Experimentally, a directable microcatheter was placed in the middle cerebral artery of baboons. Using the catheter guide wire as electrode, intracranial electrical activity was recorded from within the cerebral vessels. Significantly, depth recordings of the SEP showed waves of thalamic origin not present in surface recordings. Advantages of this method over surface recordings are the greater gain of information possible and, over other techniques of depth recording, the comparibly lesser invasiveness.

10. United States pubmed.ncbi.nlm.nih.gov

Detection of spreading depolarization with intraparenchymal electrodes in the injured human brain. [2021] Spreading depolarization events following ischemic and traumatic brain injury are associated with poor patient outcome. Currently, monitoring these events is limited to patients in whom subdural electrodes can be placed at open craniotomy. This study examined whether these events can be detected using intra-cortical electrodes, opening the way for electrode insertion via burr hole.