Spatial Cognition Assessment in Virtual Reality (CogSpa-VR)

February 9, 2023 updated by: Alma Guilbert, Université Paris Cité
Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Université Paris Cité
        • Contact:
          • Alma Guilbert

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral right stroke

Exclusion Criteria:

  • epilepsy / migraine
  • craniotomy
  • major sensory/motor deficit
  • severe cognitive impairment

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: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spatial cognition assessment
A single session of spatial cognition assessment (baseline) will be proposed to participants. This assessment will be based on paper-and-pencil tasks and immersive virtual reality tasks (with an HTC Vive Pro Head-Mounted-Display). The assessment will last around 1 hour.
Behavioral: Spatial cognition assessment
The intervention will be composed of tasks assessing spatial cognition in a real environment (cancellation task, line bisection and baking tray task) and in a virtual environment (cancellation task, line bisection, baking tray task and localization tasks).The Catherine Bergego Scale (questionnaire) will also be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omissions in cancellation tasks
Time Frame: Baseline
Number and localization in space
Baseline
Deviation in line bisection tasks
Time Frame: Baseline
Deviation of the bisection from the true center of the lines (in mm)
Baseline
Number of the cubes in each side of space in the Baking Tray Tasks
Time Frame: Baseline
16 cubes have to be disposed
Baseline
Detections in the localization tasks
Time Frame: Baseline
Number and localization in space
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of eye fixation in each side of space during VR tasks
Time Frame: Baseline
Collected thanks to the VR headset
Baseline
Completion time of each task
Time Frame: Baseline
(in s)
Baseline
Score in the Catherine Bergego Scale (CBS)
Time Frame: Assessed within the same week as Baseline
Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome
Assessed within the same week as Baseline

Collaborators and Investigators

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

Sponsor

Université Paris Cité

Collaborators

Hopitaux de Saint-Maurice
Université Paris Saclay

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)

January 1, 2022

Primary Completion (ACTUAL)

January 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogSpa-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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