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Brain PathologyNCT06565234

VR in Neurosurgery: Planning, Training & Communication

An observational study of Brain Pathology, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Pathology
How many people
60 participants
Where
1 siteSwitzerland
Study dates
10 Jun 2024to Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Attill Saemann, MD contact

+41 61 265 71 24

neurochirurgie@usb.ch

Tabea Stössel, MD contact

+41 61 265 71 24

neurochirurgie@usb.ch

Switzerland1 site, 1 recruiting

  • University Hospital Basel

    Basel, 4031

    Attill Saemann, MD, +41 61 265 71 24, neurochirurgie@usb.ch

    Attill Saemann, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions
Brain Pathology
Keywords
Intracranial Pathology, Cerebrovascular or Skull Base Pathologies, Neurosurgery, Virtual Reality, Virtual Reality-demonstration, Virtual Reality-assisted Informed Consent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for clip application

    Intraoperative timestampf for opening, dissection, aneurysm preparation, clip application and possible clip replacement

    Measured: Day 1 (Surgery)

  2. 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.

    Measured: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

  3. 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.

    Measured: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

  4. 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.

    Measured: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

  5. 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.

    Measured: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

Secondary outcomes (5)

  1. 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.

    Measured: Day 0 (before surgery)

  2. Length of hospitalization

    As a standard clinical parameter the length of hospitalization is determined.

    Measured: Up to week 1

  3. 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.

    Measured: >Day 2, Week 4, and Month 6 (after surgery)

  4. 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.

    Measured: >Day 2, Week 4, and Month 6 (after surgery)

  5. Clip Specifics

    Comparison of preoperatively planned clip and intraoperative applied clip. Clip type, length, clipping method, expectation of remnant or need for provisional clipping.

    Measured: d0 (before surgery), d1 (surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start10 Jun 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565234
Sponsor's protocol ID
2023-02009; ko23Guzman3
Other IDs
2023
Status last verified
Feb 2025
First submitted
19 Aug 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Pathology, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Attill Saemann, MD (+41 61 265 71 24, neurochirurgie@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for clip application (time frame: Day 1 (Surgery)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06565234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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