Brain Awake Surgery Using Virtual Reality Headset

NCT ID: NCT03010943

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2020-04-24

Brief Summary

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

Detailed Description

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Conditions

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Brain Tumor Virtual Reality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brain surgery with virtual reality headset

Group Type EXPERIMENTAL

Virtual reality headset

Intervention Type DEVICE

Feasibility and tolerance

Interventions

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Virtual reality headset

Feasibility and tolerance

Intervention Type DEVICE

Other Intervention Names

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awake craniotomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe MENEI, MDPHD

Role: STUDY_DIRECTOR

University hospital of Angers

Locations

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CHU Angers

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27756671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33759794 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29945859 (View on PubMed)

Other Identifiers

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2016-A01139-42

Identifier Type: -

Identifier Source: org_study_id

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