Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors

Stroke Clinical Trial

— VR-SRT  

Official title:

Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793516
• Other study ID #: E-996-17
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Kessler Foundation
• Contact: Emma Kaplan
• Phone: 973-243-6880
• Email: ekaplan[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants in this study will help test and develop a virtual reality (VR) system that is being designed to help people with spatial neglect after stroke.

Description:

Participants in this study will be tested to see if they have spatial neglect after their stroke, and the severity of such. Spatial neglect is a disorder that may occur after a stroke that leads to a person paying more attention to one side of their body over the other. Each testing session, they will perform paper and pencil neglect tests before and after playing a VR video game that is being designed as a potential future treatment. They will also give feedback on the game after the session is over. People who have spatial neglect after stroke are encouraged to apply.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Read and speak English fluently

• Have a history of one stroke event that injured one cerebral hemisphere

• Presence of moderate to severe spatial neglect

Exclusion Criteria:

• History of progressive neurological disorders

• History of significant psychiatric disorders

• History of vestibular disorders

• Living outside a 50-mile radius of Kessler Foundation (located in West Orange, NJ)

Related Conditions & MeSH terms

• Spatial Neglect
• Stroke

Intervention

Other:
• VR Therapy Game
Participants will complete 15 sessions of VR-based therapy modules developed for use in helping people with spatial neglect. These 15 sessions will be completed over 4-5 weeks.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Inattention Test	A battery of visuospatial tests using paper and pencil to perform line crossing, star cancellation, letter cancellation, line bisection, figure copying, and drawing. The test is scored from 0 to 146, with higher values indicating better performance.	At baseline, after intervention, and two weeks after intervention
Secondary	Simulator Sickness Questionnaire	A 16-item questionnaire asking for adverse feelings related to the virtual reality experience. Example items are eye strain, difficulty concentrating, headache, and burping. Each item is rated none, slight. moderate, or severe.	After intervention
Secondary	Semi-structured interview	A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.	Two weeks after intervention