VR in Neurosurgery: Planning, Training & Communication

A Prospective Observational Study on the Integration of Virtual and Augmented Reality in Neurosurgical Planning, Education, and Patient Engagement

This prospective study analyzes the broad impact of virtual reality (VR) assistance on aneurysm surgeries through two primary focuses: first, it evaluates VR-assisted clip planning by examining its clinical outcomes in the operative management of aneurysms, and second, it investigates the role of VR-assisted patient-informed consent, including its effects on patient comprehension, the patient-doctor relationship, and anxiety.

Study Overview

• Status: Recruiting
• Conditions: Brain Pathology

Detailed Description

Over the last years, increasing innovations and accessibility to virtual reality (VR) and augmented reality (AR) technologies have contributed to the relevance of these tools in daily life and medical research activities. Surgical specialties play a key role in introducing these technologies into clinical practice, with additional applications and research fields.

In neurosurgery, VR-based surgical planning for aneurysm management has shown the potential to enhance patient safety, reduce surgery times, and improve clinical outcomes. Recently, a few studies have shown that patients can also benefit from using VR applied to IC, although the current patient-oriented use of VR remains scarce.

With the increasing demand for concepts like shared decision-making and patient-centered care, optimal IC is more relevant than ever. A pilot study (NCT) on VR-based IC at the investigators' institution demonstrated feasibility and indicated positive outcomes based on the investigators' questionnaire. Building on these findings, this prospective study aims to evaluate the broad impact of VR assistance on aneurysm surgeries by focusing on two main aspects: VR-assisted clip planning, including its effects on patient safety, operative times, and clinical outcomes, and VR-assisted patient-informed consent, examining subjective patient comprehension, the patient-doctor relationship, and anxiety. Additionally, the study will assess the cost-benefit ratio and feasibility of VR-based approaches in a routine clinical setting. Ultimately, VR may foster a better understanding of complex procedures, optimize the perioperative process for both patient and surgeon, reduce anxiety, and improve patient safety.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Attill Saemann, MD; Phone Number: +41 61 265 71 24; Email: neurochirurgie@usb.ch
• Study Contact Backup: Name: Tabea Stössel, MD; Phone Number: +41 61 265 71 24; Email: neurochirurgie@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Attill Saemann, MD; Phone Number: +41 61 265 71 24; Email: neurochirurgie@usb.ch
    • Contact: Attill Saemann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for cerebrovascular or skull base pathologies at the University Hospital Basel or the University Children's Hospital Basel and/or their respective caretakers.

Description

Inclusion Criteria:

• The patient is able to give written consent (or written consent by legal representative)
• Preoperative imaging demonstrating intracranial pathology
• Cognitively able to provide answers for the questionnaires

Exclusion Criteria:

• No informed consent
• Adult patients without the power of judgement

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared Decision Making Questionnaire (SDM-Q-9)	To assess the individual experience in consenting of the patient, the Shared Decision Making Questionnaire (SDM-Q-9) is used. The SDM-Q-9 is a 9-item questionnaire designed to measure the extent of shared decision-making between patients and healthcare providers. Each item is scored on a 6-point scale from 0 (completely disagree) to 5 (completely agree). Higher scores reflect a greater involvement of the patient in the decision-making process, indicating better shared decision-making practices.	Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
Beck Anxiety Inventory (BAI)	To assess the individual experience in consenting of the patient, the Beck Anxiety Inventory (BAI) is used. The BAI is a 21-item self-report questionnaire used to assess the severity of an individual's anxiety. Each item is rated on a 4-point scale from 0 (not at all) to 3 (severely, it bothered me a lot). Higher scores indicate higher levels of anxiety, with scores categorized into minimal, mild, moderate, and severe anxiety levels.	Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
Quality of Recovery-15 (QoR-15)	To assess the individual experience in consenting of the patient, the Quality of Recovery-15 (QoR-15) is used. The QoR-15 is a 15-item questionnaire used to evaluate a patient's recovery after surgery. It covers various aspects of recovery, including physical comfort, emotional state, physical independence, psychological support, and pain. Each item is rated on an 11-point scale from 0 (none of the time) to 10 (all of the time), with higher scores indicating better quality of recovery.	Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
Time for clip application	Intraoperative timestampf for opening, dissection, aneurysm preparation, clip application and possible clip replacement	Day 1 (Surgery)
Virtual Reality-Questionnaire	To assess each patient's experience during the consent process, we use the Virtual Reality Questionnaire (VRQ). The VRQ is a numeric scale ranging from 0 (least positive experience) to 10 (most positive experience). Higher scores indicate a better (more positive) outcome in terms of the patient's overall experience. This questionnaire has been specifically customized for the study's focus on virtual reality-based interventions.	Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resources required for 3D visualization	To determine the resources required to construct the 3D model, information regarding the required time, imaging modalities, and hardware is collected.	Day 0 (before surgery)
Length of hospitalization	As a standard clinical parameter the length of hospitalization is determined.	Up to week 1
Modified Rankin Scale (mRS)	As a standard clinical parameter the Modified Rankin Scale (mRS) is assessed. The mRS is a measure used to evaluate the degree of disability or dependence in daily activities of people who have suffered neurological pathologies. The scale ranges from 0 to 6, with 0 indicating no symptoms, 1 indicating no significant disability despite symptoms, and higher scores indicating increasing levels of disability up to 5, which represents severe disability requiring constant care, and 6 indicating death. Lower scores indicate less disability, while higher scores reflect greater disability.	>Day 2, Week 4, and Month 6 (after surgery)
Extended Glasgow Outcome Scale (eGOSE)	As a standard clinical parameter the Extended Glasgow Outcome Scale (eGOSE) is assessed. The eGOSE is used to assess the functional outcome of patients after a brain pathology. The scale ranges from 1 to 8, with 1 indicating death and 8 indicating an upper good recovery with the patient resuming normal activities without disability. Lower scores indicate more severe disability or worse outcomes, while higher scores reflect better functional recovery and less disability.	>Day 2, Week 4, and Month 6 (after surgery)
Clip Specifics	Comparison of preoperatively planned clip and intraoperative applied clip. Clip type, length, clipping method, expectation of remnant or need for provisional clipping.	d0 (before surgery), d1 (surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Attill Saemann, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Neurosurgery; Intracranial Pathology; Cerebrovascular or Skull Base Pathologies; Virtual Reality-demonstration; Virtual Reality-assisted Informed Consent
• Other Study ID Numbers: 2023-02009; ko23Guzman3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No