Virtual Reality in Awake Surgery : Pilot Study VIRAS

Обзор

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.

Вмешательства

• Другое Training session with the virtual reality mask
  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)).
• Другое Monitoring of the device
  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.
• Другое Acceptability of the device
  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))
• Другое Patient state of anxiety
  Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.

Первичные конечные точки

• Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests) [Срок оценки: 1 Day]

Вторичные конечные точки (12)

• Device-related adverse event [Срок оценки: 1 Day]
• Withdrawal of the device [Срок оценки: 1 Day]
• Device tolerance for the patient [Срок оценки: 1 Day]
• Device tolerance for the medical staff [Срок оценки: 1 Day]
• Patient state of anxiety [Срок оценки: 1 Day]
• Presence of neurocognitive sequelae in patients who have undergone neurosurgery [Срок оценки: 3 months after the surgery]
• Presence of neurocognitive sequelae in patients who have undergone neurosurgery [Срок оценки: 3 months after the surgery]
• Neurological sensory-motor examination for patients who have undergone neurosurgery [Срок оценки: Three months after surgery]
• Patient state of anxiety after neurosurgery [Срок оценки: 1 Day]
• Patient state of anxiety after neurosurgery [Срок оценки: Three months after the neurosurgery]
• Patient state of anxiety after neurosurgery [Срок оценки: Three months after the neurosurgery]
• Patient state of anxiety after neurosurgery [Срок оценки: Three months after the neurosurgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Pr SEIZEUR Romuald — Brest

Идентификаторы

NCT: NCT05151822 · 29BRC21.0039 (VIRAS)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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