Brain TumorCERVO1NCT03010943
Brain Awake Surgery Using Virtual Reality Headset
A study testing Virtual reality headset in people with Brain Tumor and Virtual Reality, run by University Hospital, Angers at 1 site in France.
Trial summary
Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Virtual Reality
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2017to 24 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area
Who cannot join
- Emergency
- Any contra-indication to awake brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Brain Tumor, Virtual Reality
- Being tested
- Virtual reality headset
- Keywords
- virtual reality, glioma surgery, awake craniotomy, brain tumor, glioma, neurosurgery
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Also called awake craniotomy
Feasibility and tolerance
| Study group | Role | What they receive |
|---|---|---|
| Brain surgery with virtual reality headset | Experimental | Not described Receives: Device: Virtual reality headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.
Measured: During awake surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start17 Feb 2017
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Philippe MENEI, MDPHD, Study director, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010943
- Sponsor's protocol ID
- 2016-A01139-42
- Acronym
- CERVO1
- Status last verified
- Apr 2020
- First submitted
- 15 Dec 2016
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27756671Casanova 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.
PubMed 33759794Bernard 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.
PubMed 29945859
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance
- ClinicalTrials.gov ID
- NCT03010943
- Acronym / sponsor ID
- CERVO1 / 2016-A01139-42
- Conditions
- Brain Tumor, Virtual Reality
- Keywords
- virtual reality, glioma surgery, awake craniotomy, brain tumor, glioma, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain surgery with virtual reality headset | Experimental | Device: Virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area
Key exclusion criteria (2 listed)
- Emergency
- Any contra-indication to awake brain surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetAlso: awake craniotomyFeasibility and tolerance | Device | Brain surgery with virtual reality headset |
Primary outcome
percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.
Time frame: During awake surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Results publication: PubMed 27756671Mazerand 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.
- Derived from this study: PubMed 33759794Casanova 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.
- Derived from this study: PubMed 29945859Bernard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe MENEI, MDPHD study director
University hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Brain Tumor and Virtual Reality, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset. (time frame: During awake surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.