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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality mask | Experimental | Realization of the following examinations with virtual reality mask :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training session with the virtual reality mask | Other | 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)). |
| 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 |
| 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 |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr SEIZEUR Romuald | Recruiting | Brest | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending 15 years following the last visit of the last patient.
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.
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| Monitoring of the device | Other | 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. |
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| Acceptability of the device | Other | 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)) |
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| Patient state of anxiety | Other | Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery. |
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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 |