Spatial Cognition Assessment in Virtual Reality

NCT05723146 | Recruiting

• 1 other identifier: CogSpa-VR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spatial Neglect

Keywords

spatial neglect; virtual reality; assessment

Outcome Measures

Primary Outcomes (4)

• Omissions in cancellation tasks

  Number and localization in space

  Baseline

• Deviation in line bisection tasks

  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

  16 cubes have to be disposed

  Baseline

• Detections in the localization tasks

  Number and localization in space

  Baseline

Secondary Outcomes (3)

• Duration of eye fixation in each side of space during VR tasks

  Baseline

• Completion time of each task

  Baseline

• Score in the Catherine Bergego Scale (CBS)

  Assessed within the same week as Baseline

Study Arms (1)

Spatial cognition assessment

EXPERIMENTAL

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

Interventions

Spatial cognition assessment BEHAVIORAL

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.

Spatial cognition assessment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral right stroke

You may not qualify if:

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

Sponsors & Collaborators

• Université Paris Cité: lead
• Hopitaux de Saint-Maurice: collaborator
• Université Paris-Saclay: collaborator

Study Sites (1)

Université Paris Cité

Paris, France

RECRUITING

Central Study Contacts

Alma Guilbert, PhD

CONTACT

+33176533178; alma.guilbert@u-paris.fr

Alma Guilbert

CONTACT

+33176533178; alma.guilbert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 60 patients with right stroke will be included in this study: a group of 30 patients with USN will be compared to a group of 30 patients without USN.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: February 10, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)