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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04793516
Other study ID # E-996-17
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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