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Brain Awake Surgery Using Virtual Reality Headset (CERVO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03010943
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : April 27, 2020
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Brain Tumor Virtual Reality Device: Virtual reality headset Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brain surgery with virtual reality headset Device: Virtual reality headset
Feasibility and tolerance
Other Name: awake craniotomy

Primary Outcome Measures :
  1. percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset. [ Time Frame: During awake surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03010943

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CHU Angers
Angers, France, 49000
Sponsors and Collaborators
University Hospital, Angers
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Study Director: Philippe MENEI, MDPHD University hospital of Angers
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Angers Identifier: NCT03010943    
Other Study ID Numbers: 2016-A01139-42
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
virtual reality
glioma surgery
awake craniotomy
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases