NCT03010943

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2020

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

3.2 years

First QC Date

December 15, 2016

Last Update Submit

April 24, 2020

Conditions

Brain TumorVirtual Reality

Keywords

virtual realityglioma surgeryawake craniotomybrain tumorgliomaneurosurgery

Outcome Measures

Primary Outcomes (1)

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

    During awake surgery

Study Arms (1)

Brain surgery with virtual reality headset

EXPERIMENTAL
Device: Virtual reality headset

Interventions

Virtual reality headsetDEVICE

Feasibility and tolerance

Also known as: awake craniotomy
Brain surgery with virtual reality headset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Emergency
  • Any contra-indication to awake brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

Related Publications (3)

  • 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.

    PMID: 27756671RESULT

  • 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.

    PMID: 33759794DERIVED

  • 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.

    PMID: 29945859DERIVED

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Philippe MENEI, MDPHD

    University hospital of Angers

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

January 5, 2017

Study Start

February 17, 2017

Primary Completion

April 24, 2020

Study Completion

April 24, 2020

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

FR(1)