SurgeryVIRASNCT05151822
Virtual Reality in Awake Surgery : Pilot Study VIRAS
A study testing Training session with the virtual reality mask, Monitoring of the device and Acceptability of the device in people with Surgery, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery
- What is being tested?
- Training session with the virtual reality mask, Monitoring of the device and Acceptability of the device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2022to Aug 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 10Show fewer
- Contraindication to surgery,
- Outpatient treatment,
- Refusal or inability to consent.
- For neurosurgical patients in a awake state : Psychological/psychiatric contraindications to awake surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pr SEIZEUR Romuald
Brest
Romuald SEIZEUR, Dr, 2.98.34.25.85 ext. +33, romuald.seizeur@chu-brest.fr
Vanessa SALIOU, 2.98.34.25.85 ext. +33, vanessa.saliou@chu-brest.fr
About this study
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.
- Conditions
- Surgery
- Being tested
- Training session with the virtual reality mask, Monitoring of the device, Acceptability of the device, Patient state of anxiety
- Keywords
- Awake surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training session with the virtual reality maskOther
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)).
Monitoring of the deviceOther
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.
Acceptability of the deviceOther
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))
Patient state of anxietyOther
Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality mask | Experimental | 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 Receives: Other: Training session with the virtual reality mask; Other: Monitoring of the device; Other: Acceptability of the device; Other: Patient state of anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Day
Secondary outcomes (18)
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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 Day
Presence of neurocognitive sequelae in patients who have undergone neurosurgery
Comparison between standardized preoperative and postoperative neurocognitive assessments.
Measured: 3 months after the surgery
Presence of neurocognitive sequelae in patients who have undergone neurosurgery
Comparison between standardized preoperative and postoperative speech therapy assessments.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months after the neurosurgery
Software bug
Number of restarts required during the procedure
Measured: during the neurosurgery
Prevalence of epileptic seizures in patients who have undergone neurosurgery:
Number of seizures
Measured: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
type of seizure : Partial/generalized
Measured: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
Antiepileptic treatment received
Measured: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
EEG results
Measured: 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
Measured: During neurosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start24 May 2022
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151822
- Sponsor's protocol ID
- 29BRC21.0039 (VIRAS)
- Acronym
- VIRAS
- Status last verified
- May 2026
- First submitted
- 8 Nov 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Awake Surgery : Pilot Study VIRAS
- ClinicalTrials.gov ID
- NCT05151822
- Acronym / sponsor ID
- VIRAS / 29BRC21.0039 (VIRAS)
- Conditions
- Surgery
- Keywords
- Awake surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality mask | Experimental | Other: Training session with the virtual reality mask, Other: Monitoring of the device, Other: Acceptability of the device, Other: Patient state of anxietyRealization of the following examinations with virtual reality mask : * Training session * Acceptability of the device before and after surgery * Monitoring of the device during surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training session with the virtual reality maskPatients 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 | Virtual reality mask |
| Monitoring of the deviceIn 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 | Virtual reality mask |
| Acceptability of the deviceAfter 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 | Virtual reality mask |
| Patient state of anxietyAssessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery. | Other | Virtual reality mask |
Primary outcome
Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)
Time frame: 1 Day
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.
18 secondary outcomes
Device-related adverse event
Time frame: 1 Day
Withdrawal of the device
Time frame: 1 Day
Device tolerance for the patient
Time frame: 1 Day
Device tolerance for the medical staff
Time frame: 1 Day
Patient state of anxiety
Time frame: 1 Day
Presence of neurocognitive sequelae in patients who have undergone neurosurgery
Time frame: 3 months after the surgery
Presence of neurocognitive sequelae in patients who have undergone neurosurgery
Time frame: 3 months after the surgery
Neurological sensory-motor examination for patients who have undergone neurosurgery
Time frame: Three months after surgery
Patient state of anxiety after neurosurgery
Time frame: 1 Day
Patient state of anxiety after neurosurgery
Time frame: Three months after the neurosurgery
Patient state of anxiety after neurosurgery
Time frame: Three months after the neurosurgery
Patient state of anxiety after neurosurgery
Time frame: Three months after the neurosurgery
Software bug
Time frame: during the neurosurgery
Prevalence of epileptic seizures in patients who have undergone neurosurgery:
Time frame: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
Time frame: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
Time frame: During neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
Time frame: Three months after the neurosurgery
Characteristics of epileptic seizures in patients who have undergone neurosurgery
Time frame: During neurosurgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Surgery
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
RecruitingObservational study
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
Reconstructive Surgical Procedures, Plastic Surgery
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Recruiting
FOCUS Pre-Post Study
Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training session with the virtual reality mask, Monitoring of the device and Acceptability of the device in people with Surgery, run by University Hospital, Brest at 1 site in France.
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 5 inclusion and 10 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 18 May 2026. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests) (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.