NCT05151822 Virtual Reality in Awake Surgery : Pilot Study VIRAS
| NCT ID | NCT05151822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-05-24 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT05151822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05151822 currently recruiting?
Yes, NCT05151822 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Brest to inquire about joining.
Where is the NCT05151822 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT05151822 clinical trial?
NCT05151822 is sponsored by University Hospital, Brest. The trial plans to enroll 50 participants.