Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03010943
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : April 27, 2020
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03010943


Locations
Layout table for location information
France
CHU Angers
Angers, France, 49000
Sponsors and Collaborators
University Hospital, Angers
Investigators
Layout table for investigator information
Study Director: Philippe MENEI, MDPHD University hospital of Angers
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov 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

Layout table for additional information
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
glioma
neurosurgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases