Brain Awake Surgery Using Virtual Reality Headset (CERVO1)

April 24, 2020 updated by: University Hospital, Angers

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain surgery with virtual reality headset
Device: Virtual reality headset
Feasibility and tolerance
Other Names:
  • awake craniotomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Director: Philippe MENEI, MDPHD, University Hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Actual)

April 24, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01139-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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