NCT04288505

Brief Summary

Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with brain damage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 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

February 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

4.7 years

First QC Date

February 14, 2020

Last Update Submit

July 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance of the virtual reality application compared to classic cognitive tests batery for the detection of cognitive deficit

    from surgery to 3 months after surgery

Secondary Outcomes (6)

  • Performance of the virtual reality application compared with conventional cognitive tests used to detect visual-spatial attention disorders

    from surgery to 3 months after surgery

  • Performance of the virtual reality application compared with conventional cognitive tests used to detect facial emotion recognition disorders

    from surgery to 3 months after surgery

  • Performance of the virtual reality application compared with conventional cognitive tests, used to detect spatial attention disorders or the presence of facial emotion recognition disorders depending respectively on the location or type of facial emotion

    from surgery to 3 months after surgery

  • Study the reproducibility of the virtual reality application for detecting the presence of cognitive function disorders

    from surgery to 3 months after surgery

  • Study the correlation between visuo-spatial and facial emotion recognition deficits and possible tractographic changes

    from surgery to 3 months after surgery

  • +1 more secondary outcomes

Study Arms (1)

single arm

EXPERIMENTAL
Diagnostic Test: VIRTUAL REALITY application

Interventions

application on virtual reality headset

single arm

Eligibility Criteria

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

You may qualify if:

  • Indication for brain lesion located in the right hemisphere surgery
  • Major patient
  • Karnofsky ≥ 70

You may not qualify if:

  • Person with aphasia
  • Person with visual problems
  • Person with a contraindication to MRI
  • Person unable to carry out the tests planned in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Angers, 49000, France

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 28, 2020

Study Start

May 15, 2020

Primary Completion

February 4, 2025

Study Completion

May 5, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations