Spatial Cognition Assessment in Virtual Reality

Spatial Neglect Clinical Trial

— CogSpa-VR  

Official title:

Spatial Cognition Assessment in Virtual Reality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723146
• Other study ID #: CogSpa-VR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Université Paris Cité
• Contact: Alma Guilbert, PhD
• Phone: +33176533178
• Email: alma.guilbert[@]u-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• unilateral right stroke

Exclusion Criteria:

• epilepsy / migraine

• craniotomy

• major sensory/motor deficit

• severe cognitive impairment

Related Conditions & MeSH terms

• Perceptual Disorders
• Spatial Neglect

Intervention

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.

Locations

Country	Name	City	State
France	Université Paris Cité	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Université Paris Cité	Hopitaux de Saint-Maurice, Université Paris-Saclay

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omissions in cancellation tasks	Number and localization in space	Baseline
Primary	Deviation in line bisection tasks	Deviation of the bisection from the true center of the lines (in mm)	Baseline
Primary	Number of the cubes in each side of space in the Baking Tray Tasks	16 cubes have to be disposed	Baseline
Primary	Detections in the localization tasks	Number and localization in space	Baseline
Secondary	Duration of eye fixation in each side of space during VR tasks	Collected thanks to the VR headset	Baseline
Secondary	Completion time of each task	(in s)	Baseline
Secondary	Score in the Catherine Bergego Scale (CBS)	Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome	Assessed within the same week as Baseline