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Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors (VR-SRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04793516
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Peii Chen, Kessler Foundation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Spatial Neglect Other: VR Therapy Game Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: VR-based spatial retraining
Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.
 Other: VR Therapy Game
Participants will complete 5 sessions of VR-based therapy modules developed for use in helping people with spatial neglect. These 5 sessions will be completed over 7-8 days.


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral Inattention Test [ Time Frame: At baseline, after intervention, and two weeks after intervention ]
    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.


Secondary Outcome Measures :
  1. Simulator Sickness Questionnaire [ Time Frame: After intervention ]
    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.

  2. Semi-structured interview [ Time Frame: Two weeks after intervention ]
    A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793516


Contacts
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Contact: Jenny Masmela 973-324-3564 jmasmela@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela    973-324-3564    jmasmela@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Peii Chen, PhD Kessler Foundation
More Information
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Responsible Party: Peii Chen, Senior Research Scientist, PI, Kessler Foundation
ClinicalTrials.gov Identifier: NCT04793516    
Other Study ID Numbers: E-996-17
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases