Virtual Reality in Awake Surgery : Pilot Study VIRAS

NCT05151822 | Recruiting DMC

• 1 other identifier: 29BRC21.0039 (VIRAS)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Awake surgery

Outcome Measures

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)

  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 Outcomes (18)

• Device-related adverse event

  1 Day

• Withdrawal of the device

  1 Day

• Device tolerance for the patient

  1 Day

• Device tolerance for the medical staff

  1 Day

• Patient state of anxiety

  1 Day

Study Arms (1)

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

Other: Training session with the virtual reality mask; Other: Monitoring of the device; Other: Acceptability of the device; Other: Patient state of anxiety

Interventions

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)).

Virtual reality mask

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.

Virtual reality mask

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))

Virtual reality mask

Patient state of anxiety OTHER

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

Virtual reality mask

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Pr SEIZEUR Romuald

Brest, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 9, 2021
• Study Start: May 24, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending 15 years following the last visit of the last patient.
• 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.

Locations

FR (1)