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NCT Number: NCT05151822

Virtual Reality in Awake Surgery : Pilot Study 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pr SEIZEUR Romuald

Brest, France

Location status: Recruiting

Location contact

Céline PANHELEUX, Dr

SUB_INVESTIGATOR

Florence LE VOURC'H

SUB_INVESTIGATOR

Frédéric DUBRANA, Dr

SUB_INVESTIGATOR

Justine BLEUNVEN

SUB_INVESTIGATOR

Romuald SEIZEUR, Dr

CONTACT

[email protected]

2.98.34.25.85 ext. +33

Romuald SEIZEUR, Dr

PRINCIPAL_INVESTIGATOR

Vanessa SALIOU

CONTACT

[email protected]

2.98.34.25.85 ext. +33

Vanessa SALIOU, Dr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)).

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.

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))

Patient state of anxiety

Other

Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Device-related adverse event

    Time frame: 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.

  2. Withdrawal of the device

    Time frame: 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)

  3. Device tolerance for the patient

    Time frame: 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.

  4. Device tolerance for the medical staff

    Time frame: 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

  5. Patient state of anxiety

    Time frame: 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.

  6. Presence of neurocognitive sequelae in patients who have undergone neurosurgery

    Time frame: 3 months after the surgery

    Comparison between standardized preoperative and postoperative neurocognitive assessments.

  7. Presence of neurocognitive sequelae in patients who have undergone neurosurgery

    Time frame: 3 months after the surgery

    Comparison between standardized preoperative and postoperative speech therapy assessments.

  8. Neurological sensory-motor examination for patients who have undergone neurosurgery

    Time frame: Three months after surgery

    Evaluation with the sensory-motor profile awake (SMP-a) tool

  9. Patient state of anxiety after neurosurgery

    Time frame: 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.

  10. Patient state of anxiety after neurosurgery

    Time frame: Three months after the 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.

  11. Patient state of anxiety after neurosurgery

    Time frame: Three months after the 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.

  12. Patient state of anxiety after neurosurgery

    Time frame: Three months after the 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.

  13. Software bug

    Time frame: during the neurosurgery

    Number of restarts required during the procedure

  14. Prevalence of epileptic seizures in patients who have undergone neurosurgery:

    Time frame: During neurosurgery

    Number of seizures

  15. Characteristics of epileptic seizures in patients who have undergone neurosurgery

    Time frame: During neurosurgery

    type of seizure : Partial/generalized

  16. Characteristics of epileptic seizures in patients who have undergone neurosurgery

    Time frame: During neurosurgery

    Antiepileptic treatment received

  17. Characteristics of epileptic seizures in patients who have undergone neurosurgery

    Time frame: Three months after the neurosurgery

    EEG results

  18. Characteristics of epileptic seizures in patients who have undergone neurosurgery

    Time frame: During neurosurgery

    For intraoperative seizures only: whether or not caused by direct electrical stimulation

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: VIRAS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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