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Brain Awake Surgery Using Virtual Reality Headset (CERVO1)

Primary Purpose

Brain Tumor, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality headset
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring virtual reality, glioma surgery, awake craniotomy, brain tumor, glioma, neurosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain surgery with virtual reality headset

Arm Description

Outcomes

Primary Outcome Measures

percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2016
Last Updated
April 24, 2020
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03010943
Brief Title
Brain Awake Surgery Using Virtual Reality Headset
Acronym
CERVO1
Official Title
Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Virtual Reality
Keywords
virtual reality, glioma surgery, awake craniotomy, brain tumor, glioma, neurosurgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain surgery with virtual reality headset
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual reality headset
Other Intervention Name(s)
awake craniotomy
Intervention Description
Feasibility and tolerance
Primary Outcome Measure Information:
Title
percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.
Time Frame
During awake surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe MENEI, MDPHD
Organizational Affiliation
University hospital of Angers
Official's Role
Study Director
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27756671
Citation
Mazerand E, Le Renard M, Hue S, Lemee 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 2016 Oct 15.
Results Reference
result
PubMed Identifier
33759794
Citation
Casanova M, Clavreul A, Soulard G, Delion M, Aubin G, Ter Minassian A, Seguier R, Menei P. Immersive Virtual Reality and Ocular Tracking for Brain Mapping During Awake Surgery: Prospective Evaluation Study. J Med Internet Res. 2021 Mar 24;23(3):e24373. doi: 10.2196/24373.
Results Reference
derived
PubMed Identifier
29945859
Citation
Bernard F, Lemee JM, Aubin G, Ter Minassian A, Menei P. Using a Virtual Reality Social Network During Awake Craniotomy to Map Social Cognition: Prospective Trial. J Med Internet Res. 2018 Jun 26;20(6):e10332. doi: 10.2196/10332.
Results Reference
derived

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Brain Awake Surgery Using Virtual Reality Headset

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