Augmented Reality for Brain Injury

(PEARL Trial)

Overseen By Corey Mossop, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cooper Health System

Disqualifiers: Intracranial pathology, Experimental therapy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for placing EVDs (a type of tube used to relieve pressure in the brain) using augmented reality technology. The researchers aim to determine if this method is as safe and effective as the traditional image-guided approach. The trial seeks adults who need an EVD due to brain injury or bleeding, especially if scans show brain swelling or shifted brain structures. Participants must be patients at Cooper University Health. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future brain injury treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that augmented reality for EVD placement is safe?

Research has shown that using augmented reality (AR) to assist in placing external ventricular drains (EVDs) in the brain holds promise for safety. Previous studies have found that AR-guided EVD placement is accurate and well-tolerated by patients. For instance, one study discovered that AR is more precise than manual EVD placement, potentially reducing errors during the procedure.

Another study used a head-worn AR system to guide EVD placement and reported successful procedures without major safety concerns. Patients handled the AR system well, indicating it is a practical option.

Although few studies exist, current findings encourage those considering joining a trial. Using AR for these procedures appears safe and may offer advantages over traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using augmented reality (AR) for placing external ventricular drains (EVDs) in brain injury patients because it offers a cutting-edge approach that enhances precision. AR provides surgeons with a real-time, 3D overlay of a patient’s anatomy, potentially reducing errors and improving outcomes compared to traditional methods. On the other hand, the image-guidance technique, while also advanced, relies on pre-operative imaging without real-time updates, which might not offer the same level of adaptability during surgery. By comparing these two methods, researchers hope to find out if AR can set a new standard in neurosurgical procedures, making surgeries safer and more effective.

What evidence suggests that augmented reality is effective for EVD placement?

Research has shown that using augmented reality (AR) to place external ventricular drains (EVDs) is promising. One study found that all AR-guided EVD placements succeeded on the first try, compared to 64% with traditional methods. This suggests that AR might be more accurate than some current techniques. Another study found that AR guidance improved accuracy and quality, especially for beginners. In this trial, participants will be assigned to either the Augmented Reality Assistance arm or the Stealth Image-guided Assistance arm. These findings suggest that AR could be a reliable tool for EVD placement, potentially as effective or even better than traditional image-guided systems. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adult patients requiring an External Ventricular Drain (EVD) for conditions like spontaneous intracerebral hemorrhage with ventricular involvement or severe traumatic brain injury are eligible. Specific criteria will determine who can participate.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with a severe brain injury that includes bleeding inside the brain and ventricles.

Admitted to Cooper University Health

Exclusion Criteria

Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the investigator

Concurrent participation in another research protocol for investigation of an experimental therapy

I do not have any other brain conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Placement of EVDs using either augmented reality devices or Stealth image-guidance

During procedure

Follow-up

Participants are monitored for safety and effectiveness after EVD placement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EVD placement - AR assisted
• EVD placement - image-guidance assisted

Trial Overview The trial is testing if using augmented reality (AR) to assist in placing EVDs is at least as safe and effective as the standard image-guidance techniques currently used in medical procedures.

How Is the Trial Designed?

Group I: Augmented Reality Assistance Experimental Treatment 1 Intervention

Placement of EVDs using augmented reality device

Group II: Stealth Image-guided assistance Active Control 1 Intervention

Placement of EVDs using Stealth image-guidance

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

Citations

1. link.springer.com link.springer.com/article/10.1007/s10055-024-01033-9

Augmented reality navigation in external ventricular drain ... Current evidence demonstrates that AR is more accurate than free-hand technique for EVD insertion. However, studies are few, the technology developing,

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11980733/

Augmented reality for external ventricular drain placement This study presents a new AR-assisted approach for EVD placement, utilizing the Microsoft HoloLens 2 and the Medgital software. We conducted a ...

3. journals.lww.com journals.lww.com/neurosurgery/fulltext/2025/06000/high_accuracy_augmented_reality_guidance_for.8.aspx

High-Accuracy Augmented Reality Guidance for Intracranial... Eleven AR-guided EVD placements were performed, achieving functional placement in all cases on the first attempt, vs 7 (64%) in the control group (P = .045); ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06571539

Augmented Reality-Assisted Neurosurgical Drain Placement This study is a prospective clinical pilot study, with the goal to assess feasibility, safety and clinical performance of high-accuracy AR-guided EVD placement ...

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/51/2/article-pE8.xml

The effect of augmented reality on the accuracy and learning ... Compared with the freehand technique, AR guidance for EVD placement yielded a higher outcome accuracy and quality for procedure novices.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317059/

Augmented Reality-Guided External Ventricular Drain ... This report explores the use of a headset-based augmented reality (AR) system for guidance during the EVD placement procedure.

7. patlynk.com patlynk.com/trial/NCT07042048

Augmented Reality Assisted Ventricular Drain Placement ... This clinical trial is exploring a new way to place medical tubes called external ventricular drains (EVDs) in adults who have had a serious brain injury or ...