Virtual Reality in Awake Surgery : Pilot Study VIRAS
Recruiting now · Not applicable
Conditions studied: Surgery
In brief
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.
Key facts
- Study ID
- NCT05151822
- Run by
- University Hospital, Brest
- People needed
- 50
- Starts
- 2022-05-24
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Pr SEIZEUR Romuald — Brest, France (enrolling)
Full record on ClinicalTrials.gov
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