Surgery
Conditions
Keywords
Awake surgery
Brief 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. 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.
Interventions
OTHERTraining 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)).
OTHERMonitoring 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.
OTHERAcceptability 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))
OTHERPatient state of anxiety
Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.
Sponsors
University Hospital, Brest
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device tolerance for the medical staff | 1 Day | 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 |
| Patient state of anxiety | 1 Day | 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. |
| Presence of neurocognitive sequelae in patients who have undergone neurosurgery | 3 months after the surgery | Comparison between standardized preoperative and postoperative neurocognitive assessments. |
| Neurological sensory-motor examination for patients who have undergone neurosurgery | Three months after surgery | Evaluation with the sensory-motor profile awake (SMP-a) tool |
| Patient state of anxiety after neurosurgery | 1 Day | 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. |
| Device tolerance for the patient | 1 Day | 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. |
| Prevalence of epileptic seizures in patients who have undergone neurosurgery: | During neurosurgery | Number of seizures |
| Characteristics of epileptic seizures in patients who have undergone neurosurgery | During neurosurgery | type of seizure : Partial/generalized |
| Device-related adverse event | 1 Day | 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. |
| Withdrawal of the device | 1 Day | 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) |
| Software bug | during the neurosurgery | Number of restarts required during the procedure |
Countries
France
Outcome results
None listed