CogSpa-VR: Spatial Cognition Assessment in Virtual Reality

• Sponsor: Université Paris Cité (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05723146
• Collaborator: Hopitaux de Saint-Maurice (Other), Université Paris Saclay (Other)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spatial Neglect	Behavioral: Spatial cognition assessment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Spatial Cognition Assessment in Virtual Reality
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Omissions in cancellation tasks [Baseline]

   Number and localization in space

2. Deviation in line bisection tasks [Baseline]

   Deviation of the bisection from the true center of the lines (in mm)

3. Number of the cubes in each side of space in the Baking Tray Tasks [Baseline]

   16 cubes have to be disposed

4. Detections in the localization tasks [Baseline]

   Number and localization in space

Secondary Outcome Measures

1. Duration of eye fixation in each side of space during VR tasks [Baseline]

   Collected thanks to the VR headset

2. Completion time of each task [Baseline]

   (in s)

3. Score in the Catherine Bergego Scale (CBS) [Assessed within the same week as Baseline]

   Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• unilateral right stroke

Exclusion Criteria:

• epilepsy / migraine

• craniotomy

• major sensory/motor deficit

• severe cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université Paris Cité	Paris		France

Sponsors and Collaborators

• Université Paris Cité
• Hopitaux de Saint-Maurice
• Université Paris Saclay

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alma Guilbert, Associate Professor, Université Paris Cité
• ClinicalTrials.gov Identifier: NCT05723146
• Other Study ID Numbers: CogSpa-VR
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alma Guilbert, Associate Professor, Université Paris Cité: spatial neglect; virtual reality; assessment
• Additional relevant MeSH terms: Perceptual Disorders

Study Results

No Results Posted as of Feb 10, 2023