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NCT03010943 Clinical Trial

Brain Awake Surgery Using Virtual Reality Headset

Brain Tumor Clinical Trial

— CERVO1  

Official title:
Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03010943
Other study ID # 2016-A01139-42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2017
Est. completion date April 24, 2020

Study information
Verified date April 2020
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date April 24, 2020
Est. primary completion date April 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area

Exclusion Criteria:

- Emergency

- Any contra-indication to awake brain surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Virtual reality headset
Feasibility and tolerance

Locations
Country Name City State
France CHU Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (1)

Mazerand E, Le Renard M, Hue S, Lemée JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 20 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset. During awake surgery
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