Augmented Reality for Subdural Hematoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Unable to have CT scan, pregnancy

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 1 week

100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Augmented Reality for Subdural Drain Placement?

Research shows that augmented reality (AR) can improve the accuracy of placing drains in the brain, which is similar to the procedure for subdural hematoma. AR has been used successfully in other brain procedures, like placing ventricular drains, by helping surgeons see exactly where to place the drain, leading to better outcomes. ^{1 2 3 4 5}

Is augmented reality for subdural hematoma treatment safe?

The safety of subdural drain placement, which is part of the treatment for subdural hematoma, depends on the type of drain and surgical technique used. Some studies have reported issues like drain misplacement, but efforts are being made to reduce risks and improve safety. ^{6 7 8 9 10}

How does augmented reality for subdural drain placement differ from other treatments for subdural hematoma?

Augmented reality (AR) for subdural drain placement is unique because it uses advanced technology to guide the surgeon with real-time visual overlays, improving accuracy and reducing errors compared to traditional freehand methods. This approach can also shorten the learning curve for surgeons, making it easier to perform the procedure correctly. ^{2 3 4 5 11}

What is the purpose of this trial?

This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Research Team

Vivek Buch, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with a subdural hematoma, which is a type of brain bleed that requires drainage. Participants must be candidates for a procedure using the Subdural Evacuating Portal System (SEPS). They cannot join if they are unable to undergo CT scans or if they are pregnant.

Inclusion Criteria

I have a brain bleed that will be treated with surgery.

Exclusion Criteria

Pregnancy

You cannot have a CT scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Usability

Five patients will be enrolled to test whether the AR device functions appropriately, but no clinical decisions or changes to care will be determined by the AR device at this point.

1 week

Treatment

Participants are randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.

Approximately 1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including symptom score assessment and radiographic measures.

1 month

Treatment Details

Interventions

• Augmented Reality for Subdural Drain Placement

Trial Overview The study tests an Augmented Reality (AR) system designed to improve the accuracy of placing SEPS in patients with subdural hematomas. Initially, all participants will have both AR-guided and non-AR-guided skin markings compared for precision. Then, they'll be randomly assigned to actually receive SEPS placement either with or without AR guidance.

Participant Groups

Group I: Pilot Usability (Part 1) Experimental Treatment 1 Intervention

Five patients will be enrolled to test whether the AR device functions appropriately, but no clinical decisions or changes to care will be determine by the AR device at this point.

Group II: AR Guided SEPS Placement (Part 2) Experimental Treatment 1 Intervention

AR guidance is used to place SEPS drain

Group III: Anatomical Guided SEPS Placement (Part 2) Active Control 1 Intervention

Standard of care, non AR guided SEPS drain placement

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Subdural drains for chronic subdural hematoma (CSDH) evacuation have raised safety concerns, with misplacement rates reported as high as 17% in previous studies, indicating a need for careful consideration of drain placement techniques.

The effectiveness and safety of subdural drainage largely depend on the type of drain used and the surgical technique employed, suggesting that standardized methods, like those used in Denmark, may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drain type and technique for subdural insertion after burr hole evacuation of chronic subdural hematoma. Jensen, TSR., Poulsen, FR., Bergholt, B., et al.[2021]

In a study of 362 patients undergoing burr-hole drainage for chronic subdural hematoma, the modified Nelaton catheter (NC) technique significantly reduced the occurrence of brain contusions or new neurological deficits (1.8% vs. 10.5% with conventional technique).

The NC technique also resulted in fewer non-routine CT scans due to symptoms (5.4% vs. 36.5% with conventional technique), indicating a potential for reduced morbidity related to drain placement without compromising re-operation rates or overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing morbidity associated with subdural drain placement after burr-hole drainage of unilateral chronic subdural hematomas: a retrospective series comparing conventional and modified Nelaton catheter techniques. Moser, M., Coluccia, D., Watermann, C., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Augmented reality visualisation using an image overlay system for MR-guided interventions: technical performance of spine injection procedures in human cadavers at 1.5 Tesla. [2021]

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

App-assisted external ventricular drain insertion. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Accuracy of augmented reality-guided drainage versus stereotactic and conventional puncture in an intracerebral hemorrhage phantom model. [2023]

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

Augmented reality-assisted ventriculostomy. [2021]

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

Improved Accuracy and Lowered Learning Curve of Ventricular Targeting Using Augmented Reality-Phantom and Cadaveric Model Testing. [2023]

6. Austria pubmed.ncbi.nlm.nih.gov

Drain type and technique for subdural insertion after burr hole evacuation of chronic subdural hematoma. [2021]

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

Repeat Subdural Hematoma After Uncomplicated Lumbar Drain Discontinuation: A Case Report. [2021]

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

Drain Insertion in Chronic Subdural Hematoma: An International Survey of Practice. [2018]

9. Austria pubmed.ncbi.nlm.nih.gov

Reducing morbidity associated with subdural drain placement after burr-hole drainage of unilateral chronic subdural hematomas: a retrospective series comparing conventional and modified Nelaton catheter techniques. [2023]

10. China pubmed.ncbi.nlm.nih.gov

[Treatment of chronic subdural hematoma by minimally invasive drilling and drainage]. [2014]

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

The effect of augmented reality on the accuracy and learning curve of external ventricular drain placement. [2021]