StrokeVR-SRTNCT04793516
Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
A study testing VR Therapy Game in people with Stroke and Spatial Neglect, run by Kessler Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spatial Neglect
- What is being tested?
- VR Therapy Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read and speak English fluently
- Have a history of one stroke event that injured one cerebral hemisphere
- Presence of moderate to severe spatial neglect
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Emma Kaplan, 973-243-6880, ekaplan@kesslerfoundation.org
About this study
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.
Read the 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.
- Conditions
- Stroke, Spatial Neglect
- Being tested
- VR Therapy Game
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Therapy GameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-based spatial retraining | Experimental | Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display. Receives: Other: VR Therapy Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, after intervention, and two weeks after intervention
Secondary outcomes (2)
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.
Measured: After intervention
Semi-structured interview
A 10-minute phone interview will be conducted to explore the subjective experience of the intervention.
Measured: Two weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start25 Mar 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peii Chen, Kessler Foundation
- Investigators
- Peii Chen, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793516
- Sponsor's protocol ID
- E-996-17
- Acronym
- VR-SRT
- Status last verified
- Jun 2023
- First submitted
- 4 Mar 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Virtual Reality Spatial Retraining Therapy to Improve Neglect in Stroke Survivors
- ClinicalTrials.gov ID
- NCT04793516
- Acronym / sponsor ID
- VR-SRT / E-996-17
- Conditions
- Stroke, Spatial Neglect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-based spatial retraining | Experimental | Other: VR Therapy GameGame-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Read and speak English fluently
- Have a history of one stroke event that injured one cerebral hemisphere
- Presence of moderate to severe spatial neglect
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Therapy GameParticipants 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. | Other | VR-based spatial retraining |
Primary outcome
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.
2 secondary outcomes
Simulator Sickness Questionnaire
Time frame: After intervention
Semi-structured interview
Time frame: Two weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peii Chen, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Therapy Game in people with Stroke and Spatial Neglect, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Kaplan (973-243-6880, ekaplan@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Inattention Test (time frame: At baseline, after intervention, and two weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.