Virtual Reality in Awake Surgery : Pilot Study VIRAS (VIRAS)

The VIRAS (Virtual Reality in Awake Surgery) project is a two-stage, adaptive study. Its goal is to demonstrate the tolerance of the virtual reality (VR) headset for performing cognitive neuro-monitoring during awake brain surgery. Awake surgery involves operating on patients who remain conscious during the procedure and is most commonly employed in interventions such as tumor resections and epilepsy treatments. This approach allows surgeons to monitor and preserve critical brain functions by engaging the patient in real-time assessments of motor, sensory, and cognitive capabilities. The use of immersive distractions such as VR can help reduce anxiety and discomfort during awake craniotomy.

In order to control the risks as well as possible, the investigators have tested the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest (Saliou V, Dardenne G, Panheleux C, Le Vourc'h F, Bleunven J, Maoudj I, Longo B, Dubrana F, Yvinou A, Fernandez M, Consigny M, Nowak E, Guellec D, Seizeur R. Virtual Reality in Awake brain Surgery (VIRAS) stage I: Proof of concept and tolerance validation during scheduled orthopedic surgery. PLoS One. 2025 Sep 3;20(9):e0329894. doi: 10.1371/journal.pone.0329894. PMID: 40901801; PMCID: PMC12407469.)

The second part of the project; the equipment is tested on patients wich undergo neurosurgery in awake condition, using the same equipment and procedures as in the orthopedic cohort. An additional element will be the integration of a dedicated software application for the selection and control of neurofunctional tests. This application relies on an algorithm that incorporates both lesion laterality and tumor location, enabling dynamic adaptation of the test sequence.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Other: Training session with the virtual reality mask; Other: Monitoring of the device; Other: Acceptability of the device; Other: Patient state of anxiety

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • Recruiting
    • Pr SEIZEUR Romuald
    • Contact: Romuald SEIZEUR, Dr; Phone Number: +33 2.98.34.25.85; Email: romuald.seizeur@chu-brest.fr
    • Contact: Vanessa SALIOU; Phone Number: +33 2.98.34.25.85; Email: vanessa.saliou@chu-brest.fr
    • Principal Investigator: Romuald SEIZEUR, Dr
    • Sub-Investigator: Vanessa SALIOU, Dr
    • Sub-Investigator: Frédéric DUBRANA, Dr
    • Sub-Investigator: Justine BLEUNVEN
    • Sub-Investigator: Florence LE VOURC'H
    • Sub-Investigator: Céline PANHELEUX, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria :

• Major subject
• Consent for the study
• Patients eligible for orthopedic surgery with local anesthetic block
• Estimated duration of the Orthopedic surgery of minimum 1 hour
• For neurosurgical patients in a awake state : Patients eligible for awake neurosurgery (multidisciplinary decision: neurosurgeon, neurologist, oncologist, radiation therapist, anesthesiologist, after psychological, neuropsychological, and speech therapy evaluation)

Exclusion Criteria :

• Age < 18 years, Age > 75 years,
• Known central neurological pathology/cognitive impairment,
• Mini-Mental State examination (MMSe) < 23 if no school certificate, < 27 if school certificate,
• History of vertigo,
• Claustrophobia,
• Visual deficit not compatible with the use of the virtual reality mask,
• Contraindication to surgery,
• Outpatient treatment,
• Refusal or inability to consent.
• For neurosurgical patients in a awake state : Psychological/psychiatric contraindications to awake surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual reality mask; Realization of the following examinations with virtual reality mask : Training session; Acceptability of the device before and after surgery; Monitoring of the device during surgery

Other: Training session with the virtual reality mask; Patients will have a training session with the virtual reality mask, the day before surgery. The training consists in the realization, by the patient, of a series of language or neuropsychological tests and evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated)).; Other: Monitoring of the device; In the operating room : installation and per-operative monitoring of the device. If the device was removed, the list of device side effects or surgery-related adverse events that was required discontinuation of the device will be established.; Other: Acceptability of the device; After the surgery: evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated)); Other: Patient state of anxiety; Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)	Study the tolerance of the virtual reality mask on patients in the operating room for orthopedic surgery under loco-regional anesthesia. The mask must be maintained during the testing (minimum 1 hour). The testing consists in the realization, by the patient, of a series of language or neuropsychological tests predefined during the preoperative assessment.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related adverse event	List of device-related adverse events with Simulator Sickness Questionnaire (SSQ). SSQ quantified virtual reality mask sickness with 16 questions on a self-report basis.	1 Day
Withdrawal of the device	List of adverse events that required removal of the device (device side effects or surgery-related adverse events that may require discontinuation of the device)	1 Day
Device tolerance for the patient	Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), immediately after the training session and at the end of the procedure.	1 Day
Device tolerance for the medical staff	Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), to a representative of each profession present in the operating room during the procedure (anesthetist, surgeon, nurse), at the end of the procedure	1 Day
Patient state of anxiety	Assessing patient's state of anxiety with the STAI. The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.	1 Day
Presence of neurocognitive sequelae in patients who have undergone neurosurgery	Comparison between standardized preoperative and postoperative neurocognitive assessments.	3 months after the surgery
Presence of neurocognitive sequelae in patients who have undergone neurosurgery	Comparison between standardized preoperative and postoperative speech therapy assessments.	3 months after the surgery
Neurological sensory-motor examination for patients who have undergone neurosurgery	Evaluation with the sensory-motor profile awake (SMP-a) tool	Three months after surgery
Patient state of anxiety after neurosurgery	Assessment using the PDEQ (Peritraumatic Dissociative Experiences Questionnaire). This scale is designed to determine whether the event was experienced as potentially traumatic by identifying any psychological dissociation that occurred during or immediately after the event. The 10 PDEQ items are rated on a 5-point Likert scale (1 = not at all true to 5 = extremely true). A score of 15 or higher is considered positive, indicating significant peritraumatic dissociation.	1 Day
Patient state of anxiety after neurosurgery	Assessment using the PDEQ (Peritraumatic Dissociative Experiences Questionnaire). This scale is designed to determine whether the event was experienced as potentially traumatic by identifying any psychological dissociation that occurred during or immediately after the event. The 10 PDEQ items are rated on a 5-point Likert scale (1 = not at all true to 5 = extremely true). A score of 15 or higher is considered positive, indicating significant peritraumatic dissociation.	Three months after the neurosurgery
Patient state of anxiety after neurosurgery	Assessment using the PCL-5 (PTSD Checklist for DSM-5). This 20-item self-report scale assesses the severity of PTSD symptoms experienced in the past month. Each item is rated on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"). The total score ranges from 0 to 80. A cut-off score of 38 is used to identify probable PTSD.	Three months after the neurosurgery
Patient state of anxiety after neurosurgery	Assessment using the HADS (Hospital Anxiety and Depression Scale). This screening tool consists of 14 items divided into two 7-item subscales measuring anxiety and depression. Each item is rated on a 4-point Likert scale (0-3), giving a score range of 0-21 for each subscale. Scores above 7 is considered indicative of the presence of psychological stress.	Three months after the neurosurgery
Software bug	Number of restarts required during the procedure	during the neurosurgery
Prevalence of epileptic seizures in patients who have undergone neurosurgery:	Number of seizures	During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery	type of seizure : Partial/generalized	During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery	Antiepileptic treatment received	During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery	EEG results	Three months after the neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery	For intraoperative seizures only: whether or not caused by direct electrical stimulation	During neurosurgery

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Awake surgery
• Other Study ID Numbers: 29BRC21.0039 (VIRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending 15 years following the last visit of the last patient.
• IPD Sharing Access Criteria: Data access requests will b reviewed be the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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