跳至主要内容
临床试验/NCT05151822
NCT05151822招募中不适用

Virtual Reality in Awake Surgery : Pilot Study VIRAS

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Training session with the virtual reality mask (Other)

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

干预措施: Monitoring of the device (Other)

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

干预措施: Acceptability of the device (Other)

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

干预措施: Patient state of anxiety (Other)

结局指标

主要结局

Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验